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DENTIFRICES
Dr. AMITKUMAR
GDC&RI, BENGALURU
1
CONTENTS
• Introduction
• History
• Classification
• Functions
• Composition
• Types of dentifrices
• Factors affecting dentifrices effectiveness
• Dentifrices and the oral tissues
• Monitoring the Safety and Effectiveness
• Conclusion
• References 2
INTRODUCTION
• Dentifrices have been defined as preparations intended for use with a
toothbrush to clean the accessible tooth surfaces.
• They have been prepared in a variety of forms, including pastes,
powders, and liquids.
• The history of dentifrices dates back several centuries.
3
• According to the dictionary, the term dentifrice is derived from dens
(tooth) and fricare (to rub).
• A simple, contemporary definition of a dentifrice is a mixture used on
the tooth in conjunction with a toothbrush.
• Dentifrices are marketed as toothpowders, toothpastes, and gels. All
are sold as either cosmetic or therapeutic products.
• If the purpose of a dentifrice is therapeutic, it must reduce some
disease-related process in the mouth. Usually the actual or alleged
therapeutic effect is to reduce caries incidence, gingivitis, or tooth
sensitivity.
4
Definition
• A dentifrice is a substance used with a toothbrush to clean the
accessible surfaces of the teeth so as to provide one or more of the
following effect
1) primarily cosmetic, including cleaning, polishing, and breath
freshening
2) cosmetic therapeutic, through the efficient and thorough physical-
mechanical removal of dental plaque
3) therapeutic or pharmacologic, by means of conveying a drug
substance to the tooth surfaces or the tooth environment.
5
Forms of dentifrices
• Dentifrices can be prepared as powders, gels or toothpastes
depending on the water content.
• Toothpastes usually, but not necessarily, have high water content,
while powders have almost none.
• In gels, most of the water content is replaced by a humectant.
• Liquid dentifrice contain lesser amount of binder and detergent.
6
HISTORY OF DENTIFRICES
7
• Throughout the ages, dentifrices have been used for esthetics,
removing objectionable odors from the mouth, strengthening the
teeth, allaying dental pain and as a prophylactic to ward off epidemic
diseases
• An Egyptian medical manual, the Ebers Papyrus, written about 1500
B.C.E. and compiled from works dating to 4000 B.C.E., contains a
recipe for compounding tooth-cleaning preparations.
8
Chinese
• The Chinese described a powder to be used to prevent the progress of
caries and also to whiten the teeth.
• The major components were salt and musk. Ammonia, as a
component of urine, was also added to the mixture to enhance its
efficacy.
9
Hippocrates
• Hippocrates (460-377 B.C.E.) is generally considered the first to
recommend the use of a dentifrice.
• In his text De Morbis Mulierum, in a section dedicated to “Diseases of
Women”, he describes the “Indian medicament” used to clean teeth
and give a sweet smell to the breath.
• Hippocrates advised that one should prepare the dentifrice by
burning the head of one hare and three mice - after taking out the
intestines of two of them, but removing neither the liver nor the
kidney.
10
Celsus
• Celsus advised that one should rub the teeth with a mixture of
pounded rose leaves, gallnuts and myrrh.
• This mixture was advocated to remove stain from the teeth.
• Myrrh would most likely act as a solvent for some stains and the
powdered gall nuts as an abrasive.
11
Romans
• The Romans took great care of their teeth.
• They washed them and rubbed them with wool and made dentifrices
from burnt stag’s horn and the carbonized heads of hare, mice, and
wolves, along with the burnt heels of oxen and goat’s feet.
• Pounded egg shells, snail shells, and pumice powder were frequently
mixed with myrrh.
• The use of salt was also described by the Romans.
12
• Pliny advocated use of the ashes of the head of a hare. He stated that
any useful dentifrice could be improved by adding spikenard to
lessen the bad smell of the mouth.
• Carbonate of lime was thought to be effective and he described a
method for its preparation:
• “Egg shells should be deprived of their internal membrane and
afterwards burnt to afford a good dentifrice”.
• Scribonius Largus described a dentifrice made from barley flour
mixed into a paste with vinegar and honey.
13
• Avicenna, from Persia, was one of the early consumer advocates in
dentifrice evaluation.
• He advised his patients to avoid hard powders, as they were liable to
injure the substance of the teeth.
• He also noted the importance of remedies to remove tartar and
suggested that burnt gypsum be used.
• This bears a remarkable similarity to the pyrophosphate in use in the
20th century.
14
• Al-Bayan, a Karaite Jew born in Cairo, published a treatise called
“Hospital Formulary”.
• One chapter is devoted to medicines for the mouth and dentifrices.
• The dental pharmacotherapy was no more effective than the
remainder of the medieval physician’s pharmacopoeia.
• The basic active principles principles were astringents, germicidal
agents and abrasives.
• He described an arsenic tablet to be used for cavities and the foul
odor of the gums and to remedy deterioration of the gums.
15
• He also recommended a cooling agent to treat bleeding gums.
• This contained flower of tamarisk, dry coriander, mauve seed and
bamboo concretion.
• Two dentifrices were recommended to polish teeth, strengthen the
gums, and refine the odor of the breath.
• In most cases, the mouth was to be rinsed with vinegar and rose
water following the use of any of the dentifrices.
• Apparently gingival recession was also known at that time, as Al-
Bayan described a dentifrice to relieve pain in the teeth from cold.
16
• In England of the 17th century, popular toothpowders contained
ground china or earthenware, powdered coral, pumice, crab shells or
cuttle bone and were probably applied with a cloth.
• Charles Allen published a recipe for a dentifrice consisting of
magistery (precipitate) of pearls, powder of coral, dragon’s blood,
and red rose water, which he claimed was so good that it need only
be used once a week.
17
• The 18th century found a large number of products with greatly
inflated claims.
• In 1807, a London firm of chemists recommended the use of
charcoal as a dentifrice.
• Thomas Berdmore inveighed against vendors of destructive tooth
powders and dentifrices and gave instructions to the public with the
object of aiding them to distinguish good from bad.
• In 1746 Pierre Fauchard stated that people who used opiates,
powders and mouthwashes to clean and whiten teeth were dupes.
18
• He noted that the chief ingredients of the products were brick dust,
pumice, acid juices, spirit of vitriol and alum, all of which wore away
the enamel and produced an indelible yellow stain on the teeth.
• Fauchard described his own concoction, which he claimed would
clean and whiten the teeth, strengthen the gums and never endanger
the enamel.
• He also noted that freshly emitted urine was the best mouthwash.
19
• The American Colonies were no better.
• In 1771, Michael Poree advertised “A composition for cleaning and
preserving teeth and gums, likewise, a lotion, which is specific in all
disorders of the mouth, eradicating every degree of the scurvy,
preserving the teeth from decaying, and redoing them a very
beautiful white and sound”.
• In 1779, John Blake, described An anti-scorbutic dentifrice for
preserving teeth and gums, quite free from any corrosive
preparation.
20
• B.T. Longbothom published a treatise on dentistry in 1802, and
included a statement on “Improper Applications”.
• Parmly thought that the tooth powders, tinctures and pastes that
contained cream of tartar, alum, brick-dust, and charcoal, variously
colored and scented, could injure the teeth. He wrote:
• The best dentifrice that can be used, is common salt; it is perfectly
innocent, as it completely dissolves in saliva, and produces all the
friction necessary for cleansing the teeth.
21
• David Wemyss Jobson of Edinburgh advised in 1834 that teeth
should be scaled and then polished with a powder composed of equal
parts of pulverized pumice stone and levigated chalk.
• A Parisian dentist of the same era, J. Lefoulon, was among the first to
advocate a pre-brushing rinse (with fresh tepid water).
• After this, it is well to use some dentifrice powder, with which the
teeth and gums should be well rubbed by a hard brush.
22
• W. D. Miller ushered in a new era in the science of preventive
dentistry. In 1890, he described his chemoparasitic theory of tooth
decay.
• Miller maintained that the exciting cause of dental caries was
decalcification of the enamel by weak organic acids which created a
boom in the toothpaste industry, with each manufacturer adding
special agents or devoting his attention to separate phases of the
problem.
• The industry underwent a great change to constituents with an
alkaline base.
23
• Sodium bicarbonate and salt, separately or in combination, have been
used widely as dentifrices, their use preceding the introduction of
modern toothpaste.
• In Europe as early as 1905, Carlsbad salt, consisting of a mixture of
potassium sulfate, sodium chloride, sodium bicarbonate and sodium
sulfate, was recommended for therapy of “alveolar pyorrhea”, to be
introduced into gingival pockets after removal of deposits.
24
• In 1916, Herrick, an American physician, proposed that a saturated
solution of sodium bicarbonate be used to cleanse the mouth before
retiring.
• In the event of inflammation the powder was to be rubbed on the
gums.
• Procter and Gamble, concerned that the competition was succeeding
with whitening products, attracted attention to the dangers of
abrasion by marketing a nonabrasive liquid dentifrice, Teal@.
25
• It failed, allegedly because many users developed unsightly brown
pellicle stain.
• After World War II, many dental companies undertook scientific
studies to establish a therapeutic rationale for using any dentifrice.
• Colgate advertised their “Dental Creme” and advocated brushing
after meals.
26
• At approximately the same time, active ingredients were placed in
some dentifrices. The first to appear were urea and dibasic
ammonium phosphate (1949).
• Some of the ammoniated formulations were found to cause gingival
inflammation.
• Chlorophyll-containing dentifrices entered the scene and implanted
the word “bad breath”.
27
• Colgate marketed a sodium N-lauryl sarcosinate dentifrice and the
role of enzymes and enzyme inhibitors in promoting and preventing
dental caries became public knowledge. [Gardol@ invisible shield!
(patented in 1954)].
• Crest@ entered the market in 1955. This stannous fluoride dentifrice
is generally acknowledged to have ushered in the modern era of
therapeutic dentifrices.
• However, it was not until 1960 that the American Dental Association
allowed its Council on Dental Therapeutics to grant a seal of
provisional approval to dentifrices.
28
FUNCTIONS OF DENTIFRICES
29
• Function is described as follows
1) Cosmetic
2) Cosmetic – therapeutic
3) Therapeutic
30
Cosmetic
• Not containing a drug substance.
• Used for routine, nonspecific manner in an attempt to remove
materials like material alba, film (pellicle and plaque), food debris,
and stain from tooth surfaces.
• Net effect- cosmetically clean and healthy dentition and a fresher
breath.
31
Cosmetic – therapeutic
• Cosmetic effect
• Therapeutic effect- effect upon the incidence of caries, calculus, and
gingival disease.
32
Therapeutic
• Contain a drug substance
• Net effect- providing of the specific chemical or pharmalogic action
of drug substance, as manifested clinically by a reduction in the
incidence of caries, calculus, and gingival disease.
33
COMPOSITION OF DENTIFRICES
34
COMPOSITION OF DENTIFRICES
Ingredients N O Harris
(%)
Stallard
(%)
Melberg
(%)
SS HIREMATH
(%)
Abrasives 20-40 20-40 40-50 20-50
Water 20-40 15-50 20-30 -
Humectants 20-40 20-40 20-40 20-40
Foaming agent
(soap or detergent)
1-2 Upto 2 1-2 1-3
Binding agent Upto 2 - 0.5-2 1-3
Flavouring agent Upto 2 - 1-4 1-2
Sweetening agent Upto 2 - - 1-2
Therapeutic agent Upto 5 Upto 2 - 0.4-1
Colouring or
preservative
Less than 1 Upto 2 (colours,
preservatives,
sweeteners, stabilizers)
- <1
35
Abrasive system (Cleaning and polishing
agent)
• Substance that clean or polish the tooth surfaces are commonly
referred to as abrasives.
• Abrasivity must be sufficient to remove and prevent the buildup of
stain, but mild enough so that the enamel or exposed root surfaces
are not harmed.
Purpose
1) To remove debris, stain, and plaque from tooth surfaces.
2) To polish or impart a lustre to the tooth surfaces.
36
• The most important factors in selecting a particular abrasive for a
fluoride-containing dentifrice are its degree of abrasivity to dental
hard tissue and its compatability with fluoride.
• The degree of dentifrice abrasiveness depends on the inherent
hardness of the abrasive, size of the abrasive particle, and the shape
of the particle.
• Several other variables can affect the abrasive potential of the
dentifrice: the brushing technique, the pressure on the brush, the
hardness of the bristles, the direction of the strokes, and the number
of strokes.
37
• The abrasive tested alone can differ from the same abrasive tested as
part of a dentifrice formula.
• The salivary characteristics of individuals may also affect dentifrice
abrasiveness.
38
Various abrasives used
Insoluble sodium metaphosphate, (NaP03)x
Calcium pyrophosphate, Ca2P207
Dicalcium phosphate dihydrate, CaHP04-2H20
Dicalcium phosphate anhydrous, CaHP04
Calcium carbonate (chalk), CaC03
Alumina trihydrate, AI203-3H20
Silica, Si02
Sodium bicarbonate, NaHC03
Plastic particles. Polymethylmethacrylate
39
• Abrasives usually do not damage enamel, but they may dull the tooth
luster.
• To compensate - polishing agents are added to the dentifrice
formulation. (small-sized particles of aluminum, calcium, tin,
magnesium, or zirconium compounds)
• Typically, the manufacturer blends the abrasives and the polishing
agents to form an abrasive system.
40
• Agents, such as chalk or silica, may have both polishing and abrasive
effects.
Smaller particles (1 mm) - polishing action
larger particles (20 mm) - abrasive action.
41
Selection of dentifrices with abrasives
• Population does not accumulate visible stain when engaged in their
own style of personal oral hygiene - a dentifrice with high polishing
and low abrasion should be recommended.
• For the average individual, an additional amount of abrasive is
needed to control accumulating stain.
• As the abrasive level increases, greater care must be taken to perfect
brushing techniques that do not cause self-inflicted injury to the
teeth or soft tissues.
42
43
44
45
Humectants
• Primary function is to retain moisture and thus provide for a paste
that is chemically and physically stable.
• Toothpaste consisting only of a toothpowder and water results in a
product with several undesirable properties.
• Over time, the solids in the paste tend to settle out of solution and the
water evaporates. This may result in caking of the remaining
dentifrice.
• Until the 1930s, most toothpaste had a short shelf-life because of this
problem. Once the tube was opened, the first expelled paste was too
liquid, but the last paste in the tube was either impossible to expel or
too hard to use.
46
• To solve this problem, humectants were added to maintain the
moisture.
• Commonly used humectants are sorbitol, mannitol, and propylene
glycol.
• These humectants are nontoxic, but mold or bacterial growth can
occur in their presence.
• For this reason, preservatives such as sodium benzoate are added.
47
• Humectants help maintain the consistency of toothpaste, but despite
their presence, the solids tend to settle out of the paste.
• To counteract this, thickening or binding agents are added to the
formula.
• At high concentrations (>40%), humectants also act as preservatives.
48
Binding agent
• The binding or thickening, agent in the dentifrice holds the abrasive
in suspension.
• In general all binding agents are hydrophilic colloids that appear to
dissolve in water but actually disperse and swell to form viscous
liquid phases.
• Commonly used binding agents are sodium alginate, irish moss
extract, cellulose derivatives (eg metyl cellulose and
carboxymethylcellulose), and inorganic clay like materials such as
colloidal magnesium aluminium silicate.
49
Soaps and Detergents
• Detergents are surface active cleaning agent that
• lower surface tension,
• penetrate and loosen deposits
• suspend debris
• aid in dispersing the dentifrice and its fluoride component
throughout the mouth.
50
• Because toothpastes were originally manufactured to keep the teeth
clean, soap was the logical cleansing agent.
• Soaps have several disadvantages:
• they can be irritating to the mucous membrane (relatively high
alkaline pH),
• their flavor is difficult to mask, and often causes nausea, and
• many times soaps are incompatible with other ingredients, such as
calcium.
51
• When detergents appeared on the market, soaps largely disappeared
from dentifrices.
• Various detergents used are sodium lauryl sulfate (SLS), sodium N-
lauroyl sarcosinate, Sodium cocomonoglyceride sulfonate.
• SLS is active at a neutral pH, has a flavor that is easy to mask, and is
compatible with the current dentifrice ingredients.
52
• Barkvoll has suggested that patients who suffer from various oral
mucosal diseases should avoid the use of dentifrices containing SLS.
• Low SLS dentifrices have been marketed, which claim to be
associated with a lower incidence of oral ulcers.
53
Flavoring Agents
• Flavor, along with smell, color, and consistency of a product, are
important characteristics that lead to public acceptance of a
dentifrice.
• If dentifrices did not possess these characteristics, they would
probably be poorly accepted.
• For taste acceptance, the flavor must be pleasant, provide an
immediate taste sensation, and be relatively long-lasting.
54
• Usually synthetic flavors are blended to provide the desired taste.
Spearmint, peppermint, wintergreen, cinnamon, and other flavors
give toothpaste a pleasant taste, aroma, and refreshing aftertaste.
• Some manufacturers use essential oils such as thymol, menthol, etc.,
which may provide a "medicinal" taste to the product. In addition,
these oils may impart antibacterial effects.
55
Sweetening Agents
• In early toothpaste formulations, sugar, honey, and other sweeteners
were used.
• Because these materials can be broken down in the mouth to produce
acids and lower plaque pH, they may increase caries.
• They have been replaced with saccharin, cyclamate, sorbitol, and
mannitol, xylitol as primary noncariogenic sweetening agents.
• Sorbitol and mannitol serve a dual role as sweetening agents and
humectants.
56
Miscellaneous ingredients
• Tube corrosion inhibitors- sodium silicate
• Approved food colours
• Traces of titanium dioxide, which is used as whitening agent.
57
Other Physical forms
• Toothpowders contain essentially the same ingredients as toothpaste,
with the exception of water, humectants, or binders.
• Their capacity to clean or polish teeth (abrasivity) would depend, to a
great extent, on the degree of dilution (essentially water) that is used
with them.
58
• Liquid dentifrices, such as some “ tooth polishers” also contain
ingredients similar to those in toothpaste.
• They have lesser amount of binders and thus flow more freely.
• Some are formulated without detergents (lack foaming
characteristics).
• In general, it may not be sufficiently abrasive to maintain tooth
cleanliness, especially if they do not contain conventional quantities
of cleaning and polishing agents.
59
CLASSIFICATION OF
DENTIFRICES
60
Tooth pastes
classification
61
1.1. Fluoride concentration upto 1000
ppm
• In the 1980’s, several studies were carried out which showed that
children 2-5 years old swallow 30- 50% of the toothpaste applied to
a toothbrush.
• These studies were followed by research about the correlation
between the fluoride concentration in toothpastes and the spread of
fluorosis in permanent teeth.
• As a result, due to the risk of fluorosis, it was recommended that
children use toothpastes with a fluoride concentration of 500-550
ppm.
62
63
64
• Further it is proven that toothpastes with fluoride concentrations of
400-550 ppm do not differ from placebo toothpastes.
• Few studies with (1000-1500 ppm) showed prevalence of fluorosis,
but the severity was very mild, and caused neither clinical, nor
aesthetic problems.
• There is also evidence that when using 400 ppm or 1450 ppm
toothpastes from 1 year of age, but in strict compliance with the "pea
size" amount of toothpaste on a toothbrush, the prevalence of
aesthetically noticeable fluorosis does not differ between the two
groups.
65
1.2. Fluoride concentration 1000-1500
ppm
• The ability of toothpastes to reduce caries cited in literature varies
from 19-27% , however toothpaste with 1000 to 1500 ppm
concentrations is recognized as the most effective fluoride source.
• Children from 2-3 years of age swallow 48% of toothpaste, but
children from 6-7 years of age swallow 25% of toothpaste.
• In order to reduce the risk of fluorosis, children use toothpastes with
fluoride concentration of 1000 ppm, taking in account the age-
appropriate amount.
66
1.3. Fluoride concentration 2500-5000
ppm
• Higher concentrations in toothpastes can achieve a caries reduction
of up to 36%.
• In vitro studies also show that toothpastes with elevated
concentrations have a higher ability to remineralize enamel and
dentin better than toothpastes with normal concentrations or placebo
toothpastes.
67
Therapeutic Dentifrices
• The most commonly used therapeutic agent added to dentifrices is
fluoride, which aids in the control of caries.
• In 1960, the Council on Dental Therapeutics of the American Dental
Association - Crest toothpaste with stannous fluoride as a caries
prophylactic dentifrice (a therapeutic dentifrice was awarded the
Seal of Provisional Acceptance)
68
• The original level of fluoride in OTC dentifrices and gels was
restricted to 1,000 to 1,100 ppm fluoride and a total of no more than
120 mg of fluoride in the tube, with a requirement that the package
include a safety closure.
• Therapeutic toothpastes, dispensed on prescription, could contain up
to 260 mg of fluoride in a tube.
69
• The following fluorides are generally recognized as effective and safe
for OTC sales:
• 0.22% sodium fluoride (NaF) at a level of 1,100 ppm,
• 0.76% sodium monofluorophosphate (MFP) at a level of 1,000 ppm
• 0.4% stannous fluoride (SnF2) at a level of 1,000 ppm.
70
• Fluoride levels were increased to 1,500 ppm sodium
monofluorophosphate in "Extra Strength Aim," marketed OTC (10%
more effective than an 1,100 ppm NaF dentifrice)
• Colgate Prevident 5,000, contains 5,000 ppm fluoride.
• One baking soda-peroxide-fluoride dentifrice (Mentadent).
Mentadent contains a combination of 0.75% stable peroxide gel in
conjunction with baking soda, and 1,100 ppm sodium fluoride.
71
FLUORIDE CONTAINING THERAPEUTIC
DENTRIFICES
72
Fluoride compounds
1. Inorganic fluorides
• Sodium fluoride
• Sodium monofluorophosphate
• Stannous fluoride
• Potassium fluoride
• Aluminium fluoride
73
2. Organic fluorides
• Amine fluoride (Hetaflur)
• Amine fluoride (Olaflur)
3. Combinations of fluorides
• Amine fluoride + Sodium monofluorophosphate
• Amine fluoride + Sodium fluoride
• Sodium fluoride + Sodium monofluorophosphate
74
75
76
Sodium fluoride toothpastes
• From1945-1985 – Toothpastes with sodium fluoride have been
compared with placebo pastes.
• The first four studies (1945-1961) used toothpastes in which the
abrasive component of the toothpaste was calcium carbonate or
calcium orthophosphate, or sodium meta-phosphate.
• None of these studies showed a caries reducing effect of the products
tested.
77
• In 1961, Ericsson – in products containing calcium salts the fluoride
from the highly soluble sodium fluoride reacts to produce insoluble
calcium fluoride.
• Torrel & Ericsson (1965) – replaced conventional calcium-based
abrasive was replaced by an inert abrasive (sodium bicarbonate).
• Found Statistically significant reduction in caries increment over a 2-
year period.(18%)
• With insoluble sodium metaphosphate- caries inhibition of 9-48%
• With calcium pyrophosphate- caries inhibition of 11-38%
• 62% of trials reported= 11-30% reduction.
78
Stannous fluoride toothpastes
• There are more reported trials of stannous fluoride toothpastes than
of any of the other fluoride salts.
• Use and promotion of these toothpastes preceded sodium fluoride by
some 10 years as the first trial reported in 1955 found a sensational
49% reduction in caries increment.
• As a result of trials Council on Dental Therapeutics of the ADA first
awarded complete acceptance to a fluoride dentifrice, specifically the
stannous fluoride- calcium pyrophosphate formulation (Crest), in
1964.
79
Out of 47 studies
34 studies were with calcium pyrophosphate as abrasive.
 Most of the results were positive, with 61% of the trials reporting
caries inhibition of 11-30%
12 studies with insoluble sodium metaphosphate,
 5 compared calcium pyrophosphate with insoluble sodium
metaphosphate, although the difference was not significant.
 1 study with stannous fluoride-silica abrasive system reported 15%
caries inhibition over a 3 year period.
80
• However, the results of later clinical trials have not consistently
demonstrated statistical significance.
• The explanation for this may lie in the instability of the stannous
fluoride salt which is subject to hydrolysis with time, resulting in for-
mation of a variety of complex ions.
• Stannous fluoride toothpastes have now more or less been
abandoned not only because of the inconsistency of trial results but
also because a marked disadvantage was that these toothpastes
caused brown staining of the teeth.
81
Sodium monofluorophosphate toothpastes
• Twenty-one trials reported during the period 1963-1983, have
shown the benefits of using a monofluorophosphate toothpaste
compared with a placebo.
• The background for using this compound was twofold.
1. Monofluorophosphate had been successfully used in topical
fluoride solutions. The phosphate ion was considered important for
this purpose.
2. The results of in vitro studies which showed that this salt could be
used with calcium carbonate and other abrasives not compatible
with sodium fluoride.
82
• Although insoluble sodium metaphosphate has been the most
commonly used abrasive.
• Others like calcium carbonate, calcium pyrophosphate, silica and
alumina trihydrate has also been used.
• 71% of the clinical trials found caries inhibition of 11-30% &
• 50% were between 21-30%.
• 3 clinical trials compared SnF with MFP and found that MFP is
slightly more effective than SnF toothpastes.
83
• The first product, Colgate MFP, used insoluble sodium
metaphosphate as the abrasive system, and this formulation was
shown to reduce the incidence of caries in children by as much as
34%.
• On the basis of these studies, this dentifrice was approved as safe and
effective by the FDA in 1967 and accepted by the ADA in 1969.
84
Amine-fluoride toothpastes
• The philosophy behind using an organic fluoride compound in a
toothpaste was based on studies which suggested that uptake of
fluoride in enamel could be enhanced by using a substance with
affinity for the enamel surface.
• Also, in vitro studies had demonstrated that amine fluorides could
reduce enamel solubility and retard enzyme activity in plaque.
85
• Only few trials have been reported.
• The results were encouraging but the last trial conducted in USA
gave negative results and possible toxicity of the compound has been
questioned.
86
Comparison of NaF and MFP toothpaste
• Subsequent literature reviews compared all available clinical data
regarding the relative efficacy of compatible sodium fluoride
dentifrices and those containing sodium monofluorophosphate.
• Using different statistical procedures, these reviews concluded that
sodium fluoride was significantly more effective than sodium
monofluorophosphate.
• Based on a meta-analysis, it was concluded that the magnitude of this
difference was 7%.
87
• It is interesting that many fluoride dentifrices contain mixtures of
sodium fluoride and sodium monofluorophosphate with a total
fluoride content of 1,500 ppm.
• Clinical efficacy data of these latter systems have also been reviewed
with the conclusion that they are numerically less effective than an
equivalent concentration of bioavailable sodium fluoride.
88
Other fluoride dentifrices
• Dentifrice containing 0.125% fluoride, provided by
1 diethanol aminoprpphyl-N-ethanol octa-decylamine-
dihydrofluoride
2. cetylamine hydrofluoride
89
Fluoride abrasive compatibility
• Of major importance to fluoride containing dentifrices is the
compatibility of the abrasive with the fluoride source.
• Inactivation can occur through reactions forming calcium fluoride
or Fluorapatite, by adsorption to the abrasive surface, or by
complexing with soluble ions.
• The compatibility of calcium-containing abrasives has been
improved by modification of their chemical and physical forms.
90
Compatibility
Insoluble
sodium
metaphos
phate,
(NaP03)x.
Calcium
pyrophos
phate,
Ca2P207.
Dicalcium
phosphate
dihydrate,
CaHP04-
2H20.
Dicalcium
phosphate
anhydrous,
CaHP04.
Calcium
carbonate
(chalk),
CaC03.
Alumina
trihydrate,
AI203-3H20.
Silica, Si02. Sodium
bicarbona
te,
NaHC03
Plastic
particles
NaF Y Y N N N N Y Y Y
SnF Y Y N N N N Y Y Y
MFP Y Y Y Y Y Y Y Y Y
Abrasivity Moderate Moderate Mild High Varies Moderate Moderate Mild Low
91
Fluoride toothpaste and oral clearance
• Chesters et al. (1992) drew attention to the fact that the method of
oral rinsing after using F-toothpaste, and the frequency of
toothbrushing, can both have a relationship with caries increments
in clinical trials.
• The DMFs increment in this study was highest (6.9) when a beaker
was used to rinse away toothpaste followed by ‘using a brush’ (5.9),
putting ‘head under tap’ (5.8) and ‘using hand’ (5.5.).
• The caries increment for those who brushed once per day or less was
higher (7.0) than those who brushed twice per day or more (5.4).
92
• From these results it may be concluded that the greatest reduction in
DMFs increment occurs when brushing at least twice per day and
rinsing by means of hand under the tap.
• Similar findings have been reported by Ashley et al. 1999.
93
94
Fluoride dentifrices and dental fluorosis
• Several reports have indicated an increasing prevalence of fluorosis
in the United States by the use of fluoride dentifrices.
• A national survey of U.S. children conducted between 1986 and
1987 indicated that about 22% displayed some evidence of dental
fluorosis; however, it is important to note that, in terms of severity, a
majority had either very mild or mild fluorosis, and only about 1%
were classified as moderate or severe.
95
• These considerations have prompted the ADA to recommend that
children under age 3 should be advised to use only a "pea-sized"
quantity of a fluoride dentifrice for brushing and that this quantity
be gradually increased with age so that not until age 6 is the child
using a "full-strip" of dentifrice on the brush head.
• Using no more than a ‘smear’ or ‘rice-size’ amount of fluoridated
toothpaste for children less than three years of age may decrease risk
of fluorosis. Using no more than a ‘pea-size’ amount of fluoridated
toothpaste is appropriate for children aged three to six. (AAPD 2014)
96
NON FLUORIDE
CONTAINING THERAPEUTIC
DENTIFRICES
97
Chlorophyll containing dentifrices
• Water soluble derivatives of chlorophyll are used.
• Use is based on the ability of chlorophyll to reduce bacterial growth
and to reduce acid formed in dental plaque.
• Specific compound utilized is – sodium copper chlorophyllin.
• Only animal studies
• Out of 4, only 1 study showed benefit against gingival disease.
• Currently not accepted by ADA.
98
Antibiotic containing dentifrices
• Based on premise to destroy or inactivate the microorganisms that
are associated with oral disease.
• Studies have been conducted with toothpowders containing
penicillin and erythrocin containing dentifrices.
• Out of 6, four studies showed decrease in caries incidence.
• However FDA opposed the regular use of antibiotics due to several
reasons.
99
Ammonium containing dentifrices
• Urea and dibasic ammonium phosphate have been used in dentifrices.
• Based on theory that ammonia and urea can neutralize the acid
produced by acidogenic bacteria in dental plaque.
• Also urea could function as an enzyme inhibitor by virtue of its
protein denaturant properties.
• Studies have shown positive results for caries reduction. However
ADA has not recommended urea or ammonium compound as active
ingredients in dentifrices.
100
Enzyme inhibitor containing dentifrices
• Theory was suggested that dental plaque might serve as medium for
the retention of enzyme inhibitor on the tooth surface, where they
would be available to prevent the enzymatic conversion of sugar into
acid.
• Few formulations have been used are
• 2% sodium N-lauroyl sarcosinate
• 0.75% sodium dehydroacetate
• 0.5% sodium oxalate
101
• ADA has indicated that evidence in support of antienzyme dentifrices
is controversial and that usefulness of these dentifrices in caries
control has not been adequately established.
102
Baking-Soda Dentifrices
• Baking soda (sodium bicarbonate) has had a long history of use as an
oral-hygiene aid.
• In a series of papers published in 1998, antiplaque, gingivitis
reduction, stain-removal, and odor-reducing efficacy were
documented for sodium bicarbonate-containing dentifrices.
• Some dentists have also suggested the mixture of baking soda with
peroxide as an alternative to the use of commercial dentifrices.
103
• No dentifrice containing baking soda as the sole active ingredient has
received the ADA Seal of Acceptance.
• It was only after fluoride was added to the formulations, and after
required laboratory, animal, and clinical studies were completed,
that several baking soda-fluoride dentifrices were accepted as
effective in caries control.
• These baking-soda dentifrices actually contain only a small amount
of baking soda, in addition to the standard fluoride-compatible
abrasives.
104
Essential-Oil Dentifrices
• The essential-oil ingredients found in Listerine mouthrinse are also
available in a dentifrice formulation.
• The clinical and laboratory data suggest a benefit to gingival health
and plaque reduction.
• This product does not carry the ADA Seal of Acceptance.
105
Anticalculus Dentifrices
• Calculus-control dentifrice formulations are designed to interrupt
the process of mineralization of plaque to calculus.
• Crystal growth inhibitors may be added to dentifrices to provide a
reduction in calculus formation.
• In the late 1970s, anticalculus dentifrices began to appear on the
market without any evidence of effectiveness.
106
• In 1985, Procter & Gamble supplemented their existent Crest
anticariogenic toothpaste with a similar anticaries formula that also
contained a combination of tetra sodium phosphate and disodium
dihydrogen pyrophosphate (crystal growth inhibitors). (Crest Tartar
Control)
• This combination has been demonstrated in clinical studies to
significantly reduce the amount of calculus formed, compared with a
control dentifrice.
107
• The formula received the American Dental Association's Seal of
Acceptance, but only as a caries control product and only because of
its fluoride content.
• Other similar anticalculus products that are now on the market all
contain NaF.
108
• Rolla and Saxegaard have noted the possibility of "crystal poisons,"
such as pyrophosphates and phosphonates, inhibiting
remineralization. Such inhibition might adversely affect the
anticaries effect of the fluoride in this type of calculus control
dentifrice.
• Zinc citrate trihydrate is used to inhibit calculus formation in the
tartar control versions of both Aim and Close-Up. Clinical studies
have shown that zinc citrate does not affect the caries inhibition of
fluoride.
109
• Despite favorable anticalculus data, the ADA seal has not been
awarded to products with only an anticalculus claim, because the
ADA considers calculus inhibition as a cosmetic, not a therapeutic
effect.
• With an anticalculus agent, two simultaneous beneficial effects
caries control and calculus inhibition are available with one
brushing operation.
110
Antihypersensitivity Products
• Several OTC dentifrices have been accepted with the active agents
such as potassium nitrate, strontium chloride, and sodium citrate.
• These therapeutic dentifrice are directed simultaneously at solving
two problems, caries and hypersensitivity, with the same brushing
operation.
111
Analgesic toothpastes
• Toothpastes containing potassium saline maintain a high K+
extracellular level, thus preventing re-polarization of the nerve cell
membrane and inhibiting the transmission of impulse.
• Based on studies, improvement was observed in 85% of the cases.
Toothpaste, which is composed of 5% or 10% potassium nitrate, can
decrease tooth sensitivity for up to 4 weeks.
• However the authors of the Cochrane systematic review do not find
sufficient evidence of the clinical efficacy of potassium salts in the
reduction of dentin hypersensitivity
112
Dentin tubule blocking toothpastes
• Stannous fluoride possesses the ability to block tubules, forming SnF2
and CaF2, and the ability to form a protective layer on the tooth
surface, by creating a reaction of Sn2+ ion with sodium, calcium and
phosphate compounds and forming Sn-Na hexametaphosphate.
• In addition, by adding calcium and phosphate ions, they combine
with the fluoride ions on the enamel surface and form an amorphous
calcium phosphate, which in addition to blocking tubules, also
smoothes the tooth surface, achieving an even more effective
reduction of sensitivity.
113
• Toothpastes containing arginine also yield good results in the
reduction of dentin hypersensitivity they can block the dentin
tubules.
• In several studies it has been proven that the clinical hyposensitive
effect of arginine is greater than that of potassium salts and fluoride.
• Based on recent systematic review the arginine/calcium carbonate-
based toothpaste provided a higher level of efficacy in terms of DH
relief than the strontium-based toothpaste.
114
115
116
American Journal of Dentistry, Vol. 23, Sp. Is. A, May, 2010
117
American Journal of Dentistry, Vol. 23, Sp. Is. A, May, 2010
Lead tube to Plastic Packaging
• The change to plastic packaging during World War II
simultaneously:
• Eliminated the possibility of the user ingesting lead,
• Reduced the possibility of incompatibility of the tube and paste
components,
• Aided the expelling of the paste by squeezing,
• Permitted an easier and more economic production of tubes, and
• Provided a good surface for the printing of decorative designs and
information.
118
Risk for fluorosis
• Use of a pea-sized amount (approximately 0.25 g) of fluoride
toothpaste <2 times per day by children aged <6 years is reported to
sharply reduce the importance of fluoride toothpaste as a risk factor
for enamel fluorosis.
• Since 1991, manufacturers of fluoride toothpaste marketed in the
United States have, as a requirement for obtaining the ADA Seal of
Acceptance, placed instructions on the package label stating that
children aged <6 years should use only this amount of toothpaste.
119
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5014a1.htm
Fluoridated dentifrice for children
• Toothpaste labeling requirements mandated by FDA in 1996 also
direct parents of children aged <2 years to seek advice from a dentist
or physician before introducing their child to fluoride toothpaste.
120
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5014a1.htm
• Fluoride Toothpaste
• Fluoride toothpaste is widely available, no more expensive than
nonfluoride toothpaste, and periodically improved.
• Use of a pea-sized amount (0.25 g) twice per day requires
approximately two tubes of toothpaste per year, for an estimated
annual cost of $6--$12, depending on brand, tube size, and retail
source.
121
122
123
Whiteners
• These dentifrices control stain via physical methods (abrasives) and
chemical mechanisms (surface active agents or bleaching/oxidizing
agents).
• Although the public perceives these as more abrasive than ordinary
toothpastes, their abrasiveness is usually intermediate among the
products tested.
• Dentifrices marketed with tooth-whitener claims are available as a
toothpaste or gel, or are used in a two- or three-step treatment
"process."
124
• These products usually contain hydrogen peroxide or carbamide
peroxide as their bleaching or whitening ingredient.
• Carbamide peroxide breaks down to form urea and hydrogen
peroxide.
• Hydrogen peroxide, in turn, forms a free radical containing oxygen,
which is the active bleaching molecule.
• Home-bleaching products may contain other chemicals to aid in the
delivery of the bleaching agent.
125
• Glycerin or propylene glycol is commonly added to thicken the
solution and prolong contact with the tooth surface.
• In the two- or three-step products, agents can be delivered to teeth
via a custom-made tray or by toothbrushing.
• Side-effects includes, overgrowth of undesirable organisms,
including yeasts, possibly leading to "black hairy tongue, damage the
pulp or the soft tissues of the mouth, delayed wound healing.
126
• The Food and Drug Administration has classified these products as
drugs.
• The American Dental Association's Council on Scientific Affairs has
issued "Guidelines for the Acceptance of Peroxide Containing Oral
Hygiene Products."
127
Antiplaque and AntigingivitisToothpastes
• Term antiplaque refers more often to agents capable of significantly
reducing plaque levels and antigingivitis to agents capable of
significantly reducing gingivitis levels.
• Antiplaque activity may be achieved by different mechanisms of
action: (a) by preventing bacterial adhesion; (b) by limiting bacterial
growth and/or coaggregation; (c) by disrupting an already
established biofilm; (d) by altering the composition and/or
pathogenicity of the biofilm
128
Composition
Enzymes
• Specific agents include glucose oxidase and amyloglucosidase.
• Their mechanisms of action rely on the catalyzation of thiocyanate
into hypothiocyanite through the salivary lactoperoxidase system.
Amine Alcohols
• Specific agents include delmopinol and octapinol. Their mechanism
of action is through the inhibition and disruption of the biofilm
extracellular matrix, and therefore they are not antimicrobial agents
since they disrupt an already established biofilm.
• They also inhibit glycan synthesis by Streptococcus mutans and thus
reduce bacteria acid production.
129
Metal Salts: Zinc Salts
• Specific agents include zinc lactate, zinc citrate, zinc sulphate or zinc
chloride.
• Zinc salts have shown antibacterial action due to their ability to
inhibit bacterial adhesion, metabolic activity and growth.
• Zinc products have been evaluated for plaque control, but also
focused on halitosis control, or healing properties in presence of
ulcers
130
Metal Salts: Stannous Fluoride
• Stannous fluoride has been included in dentifrices and gels since
1940s.
• The mechanism of action of the stannous ion is through adherence to
the bacterial surface, inhibition of bacterial colonization, penetration
into the bacteria cytoplasm and interference with the bacterial
metabolism.
131
Natural Products
• Specific agents include sanguinarine extract and other herbal
ingredients (chamomile, echinacea, sage, myrrh, rhatany, peppermint
oil).
Triclosan
• Triclosan [5-chloro-2-(2, 4 dichlorophenoxy) phenol] is a non-ionic
bisphenolic, broad-spectrum antibacterial agent.
• Triclosan has been widely formulated in dentifrices usually in
combination with polyvinyl-methyl ether maleic acid copolymer,
zinc citrate or pyrophosphate, in order to improve the substantivity
and/or the antimicrobial activity.
132
• Triclosan has also demonstrated anti-inflammatory effects through
the inhibition of the cyclooxygenase and lipoxygenase pathways, by
reducing the synthesis of prostaglandins and leukotrienes.
Bisbiguanides: Chlorhexidine
• CHX is an active agent against Gram-positive and Gram-negative
bacteria, yeasts and viruses.
133
Quaternary Ammonium Compounds
• Specific agents include benzylconium chloride and Cetylpyridinium
chloride (CPC).
• Their mechanisms of action rely on the hydrophilic part of the CPC
molecule that interacts with the bacterial cell membrane, leading to
its disruption, alteration of the bacterial cell metabolism growth
inhibition and finally cell death.
134
Dentifrices with specialized function
• It was supplied by Dr. Ira L. Shannon, a dental consultant to Johnson
Space Center associated with the Oral Disease Research Laboratory of
the Veterans Administration Hospital in Houston.
• Developed in response to the specific needs of astronauts while in
space missions.
• This ingestible dentifrice, designed to assist in maintaining oral
hygiene during prolonged periods of chamber confinement.
135
• It was formulated within the following limitations
1) no volatile oils
2) no detergent (or foaming agent)
3) low calcium content
136
Ingestible dentifrice contains the following ingredients
• Insoluble sodium metaphosphate(40%)
• Dicalcium phosphate dehydrate(2.6%)
• Glycerine (32%)
• Carboxymethylcellulose (1.3%)
• Saccharin (0.1%)
• Distilled water (24%)
137
• Comparison tests with a commercially available dentifrice showed
that there was no significant difference in the cleaning ability and
user acceptance of the two types of toothpaste.
• Applied without water, the pleasantly-flavored ingestible toothpaste
has been used for years by astronauts in space and on Earth.
• Important aid to maintaining oral hygiene among patients in
hospitals, nursing homes and other special care facilities
138
• It also offers major benefit to certain categories of patients, such as
those bed-confined in hospital wards who might not have facilities
for expectoration; paraplegics confined to wheelchairs; patients with
oral-facial paralysis whose ability to expectorate is limited; the
mentally handicapped; and others whose illness require that
attendants carry out the tccthbrushing for them.
139
Herbal Dentifrices
• Herbal toothpastes, at least the ones on retail shelves in India, cater to
the demand of consumers who want ‘natural’ alternatives to
chemical-based products.
• there is not much difference in the texture or consistency of the
herbal toothpastes when compared to conventional toothpastes, and
are different mainly in colour and flavour.
• Most herbal toothpastes do not look pristine white, but have a range
of colours and also tend to taste rawer and less sweet.
140
• However, herbal toothpastes should ideally not contain any
unnatural chemical, dyes or artificial flavours and preservatives, and
should be made with only natural ingredients. Unfortunately, no
brand in India can claim to be that ‘natural’.
• No ‘significant’ difference exist between regular toothpastes and the
herbal ones.
141
• Ordinary or regular (non-herbal) toothpaste includes abrasives or
excipient (calcium carbonate and silica), foaming agents
(surfactants), anti-cavities fluoridation, flavouring agents and
sweetening agents (sodium saccharin).
• These ingredients form over 90 per cent of the paste and the rest 10
per cent is generally those added flavours or other agents that
become differentiation elements and also help in creating a unique
selling proposition (USP) that brands talk about in their marketing
messages.
• When this 10 per cent element also includes 2.5 per cent of herbal
extracts or Ayurvedic elements, the paste becomes herbal – in any
case, that is what a consumer is made to believe.
142
143
Factors Affecting Dentifrice Effectiveness
• In addition to the inherent properties of a fluoride dentifrice product,
biological and behavioral factors can modify its anticaries
effectiveness.
• All of these factors interplay in what can be described as the
"application" phase (the initial interaction of relatively high
concentrations of fluoride with the tooth surface and plaque), and
the "retention“ phase (the fluoride remaining in the mouth after
brushing that is retained in saliva, plaque and plaque fluid, the tooth
surface, and oral soft tissue reservoirs).
144
• Behavioral factors include the frequency of dentifrice use, length of
brushing, rinsing practices after brushing, the time of day that
dentifrice is applied, and amount of dentifrice applied to the brush.
• It is well established that the frequency of use has a major influence
on effectiveness.
• Bushing twice per day or more has a greater preventive effect than
once per day.
145
• Length of the brushing time (application phase) determines how long
the relatively high fluoride concentration in the dentifrice slurry
stays in contact with the teeth and plaque, allowing fluoride uptake
to take place.
• The higher the fluoride concentration, the greater the driving force
for fluoride diffusion through plaque toward the tooth surface.
• Rinsing behaviors after toothbrushing affect the amount of fluoride
retained in the mouth and have been reported to affect caries
experience.
146
• Physiologic (biological) factors, mainly salivary flow rate during and
after fluoride application influence the rate of fluoride clearance.
• Bedtime use of fluoride dentifrice results in longer fluoride retention
than daytime application due to greatly decrease salivary flow during
sleep.
• The amount of fluoride applied to the toothbrush (dose) is not as
important as the concentration of available fluoride in a dentifrice.
147
DENTRIFICES AND THE ORAL
TISSUES
148
Effect on mucosa
• Every commercially available dentifrice has been reported to be
associated with some type of reaction. (i.e particular type of reaction
in particular person)
• But the incidence of mucosal reactions are relatively small.
• Allergic reactions and contact dermatitis caused by the ingredients in
toothpaste have been reported.
• Some studies have documented allergic reactions to the flavorings
used, especially cinnamic aldehyde.
• Others have reported skin reactions to the preservatives, especially
sodium benzoate, and to aluminum.
149
• Still others have shown contact dermatitis caused by sodium lauryl
sulfate and propylene glycol.
• Dentist can advice the person to discontinue the particular dentifrice
and use another brand, if it is associated with mucosal reaction.
• If the person continues to experience the reaction with a new
product, then a more generalized allergic- type response should be
suspected.
• The person should be referred to a dermatologist for further
evaluation and examination.
150
Monitoring the Safety and Effectiveness of
Therapeutic Dental Products
• There are three levels of regulation of oral chemotherapeutic agents.
The government level includes the Food and Drug Administration
(FDA) and the United States Pharmacopoeia Convention.
• The professional or voluntary level includes the Council on Scientific
Affairs (CSA) of the American Dental Association (ADA).
• The third level of review includes consumer advocacy organizations,
advertising standards review panels, and the Federal Trade
Commission
151
• The stages of FDA approval include preclinical research and
development (animal testing, laboratory testing, and toxicity
evaluation)
• Clinical research conducted with an approved investigational new
drug (IND) application. (Three phases)
• After the company receives an approved new drug application
(NDA), marketing may begin, but post-marketing surveillance of the
product is mandatory.
152
• Over the years, the FDA has requested manufacturers of OTC
products to submit a listing of the active and inactive ingredients in
their products as a basis for helping to codify regulations governing
OTC sales.
• All inactive ingredients be listed on the label by quantity in
descending order.
• Active ingredients, as well as inactive agents, should be in no higher
concentrations than necessary for the intended purpose.
153
• The panel also recommended that the indicated objective of the active
agent(s) must be on the label and that the inclusion of the name of an
active agent(s) without stating the proposed benefits would be
considered misleading.
• Recommendations also apply to packaging and labeling guidelines to
regulate advertising.
• For example, the recommendations suggest that all containers for
OTC therapeutic dentifrices, rinses, and gels containing fluoride have
a label to identify the product, e.g., "anticaries dentifrice"; its use, e.g.,
"aids in the prevention of dental caries"; a warning, e.g., "Do not
swallow.
154
155
CONCLUSION
• Dentifrices are normally used in combination with toothbrushing,
providing a cosmetic (cleaning, fresh breath) and often also a
therapeutic (caries, periodontal diseases, halitosis control) benefit.
• Different ingredients have been included as active components in
dentifrice formulations depending on the therapeutic claim.
• Dentifrices represent the ideal vehicle for the application of active
agents in the prevention (and therapy) of the most prevalent oral
diseases, caries and periodontal diseases, since they are used in
combination with toothbrushing, perhaps the most compliant
behavior of modern human beings.
156
REFERENCES
• Melberg JR, Ripa LW, Leske GS. Fluoride in preventive dentisry. Theory and clinical applications. 1983, Quintessence
publishers, Chicago.
• Fejerskov O, Ekstrand J, Burt BA. Fluoride in dentistry. 2nd ed. 1996. Munksgaard publishers, Copenhagen.
• Harris NO, Garcia-Godoy F. Primary preventive dentistry. 6th ed. 2004. Pearson prentice Hall, New Jersey .
• Comprehensive Preventive Dentistry. Hardy Limeback. Wiley-Blackwell in Oxford, UK.
• Axelsson P. An introduction to risk prediction and preventive dentistry. Vol 1. Quintessence publishing Co., Germany.
1999.
• Stallard RE. A textbook of preventive dentistry. 2nd ed. WB Saunders, USA. 1982.
• Hiremath SS. Textbook of preventive and community dentistry. 2011. 2nd ed. Elsevier publishers, New Delhi.
• Maldupa I, Brinkmane A, Rendeniece I, Mihailova A. Evidence based toothpaste classification, according to certain
characteristics of their chemical composition. Stomatologija. 2012;14(1):12-22.
• Twetman S. Caries prevention with fluoride toothpaste in children: an update. Eur Arch Paediatr Dent. 2009
Sep;10(3):162-7.
• Davies R, Scully C, Preston AJ. Dentifrices--an update. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e976-82
157
REFERENCES
• Wong MC, Clarkson J, Glenny AM, Lo EC, Marinho VC, Tsang BW, Walsh T, Worthington HV. Cochrane reviews on
the benefits/risks of fluoride toothpastes. J Dent Res. 2011 May;90(5):573-9.
• Demarco FF, Meireles SS, Masotti As. Over-the-counter whitening agents: a concise review. Braz Oral Res. 2009;23 Suppl 1:64-
70.
• Sanz M, Serrano J, Iniesta M, Santa Cruz I, Herrera D. Antiplaque and antigingivitis toothpastes. Monogr Oral Sci. 2013;23:27-
44.
• Glass RL. Fluoride dentifrices: the basis for the decline in caries prevalence. J R Soc Med. 1986;79 Suppl 14:15-7.
• Ingestible Toothpaste http://ntrs.nasa.gov/archive/nasa/casi.ntrs. nasa.gov/20020091883.pdf. Accessed on 4-05-2105.
• Magno MB, Nascimento GC, Da Penha NK, Pessoa OF, Loretto SC, Maia LC. Difference in effectiveness between strontium acetate
and arginine-based toothpastes to relieve dentin hypersensitivity. A systematic review. Am J Dent. 2015 Feb;28(1):40-4.
• Cummins D. Advances in the clinical management of dentin hypersensitivity: a review of recent evidence for the efficacy of
dentifrices in providing instant and lasting relief. J Clin Dent. 2011;22(4):100-7.
• Riley P, Lamont T. Triclosan/copolymer containing toothpastes for oral health. Cochrane Database Syst Rev. 2013.
• S.A. Lavender, I. Petrou, R. Heu, M.A. Stranick, D. Cummins, L. Kilpatrick-Liverman, R.J. Sullivan & R.P. Santarpia. Mode of action
studies of a new desensitizing dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm
fluoride. Volume 23, Special Issue A, May, 2010 - p. 1A – 40A.
158
159

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DENTIFRICES.ppt

  • 2. CONTENTS • Introduction • History • Classification • Functions • Composition • Types of dentifrices • Factors affecting dentifrices effectiveness • Dentifrices and the oral tissues • Monitoring the Safety and Effectiveness • Conclusion • References 2
  • 3. INTRODUCTION • Dentifrices have been defined as preparations intended for use with a toothbrush to clean the accessible tooth surfaces. • They have been prepared in a variety of forms, including pastes, powders, and liquids. • The history of dentifrices dates back several centuries. 3
  • 4. • According to the dictionary, the term dentifrice is derived from dens (tooth) and fricare (to rub). • A simple, contemporary definition of a dentifrice is a mixture used on the tooth in conjunction with a toothbrush. • Dentifrices are marketed as toothpowders, toothpastes, and gels. All are sold as either cosmetic or therapeutic products. • If the purpose of a dentifrice is therapeutic, it must reduce some disease-related process in the mouth. Usually the actual or alleged therapeutic effect is to reduce caries incidence, gingivitis, or tooth sensitivity. 4
  • 5. Definition • A dentifrice is a substance used with a toothbrush to clean the accessible surfaces of the teeth so as to provide one or more of the following effect 1) primarily cosmetic, including cleaning, polishing, and breath freshening 2) cosmetic therapeutic, through the efficient and thorough physical- mechanical removal of dental plaque 3) therapeutic or pharmacologic, by means of conveying a drug substance to the tooth surfaces or the tooth environment. 5
  • 6. Forms of dentifrices • Dentifrices can be prepared as powders, gels or toothpastes depending on the water content. • Toothpastes usually, but not necessarily, have high water content, while powders have almost none. • In gels, most of the water content is replaced by a humectant. • Liquid dentifrice contain lesser amount of binder and detergent. 6
  • 8. • Throughout the ages, dentifrices have been used for esthetics, removing objectionable odors from the mouth, strengthening the teeth, allaying dental pain and as a prophylactic to ward off epidemic diseases • An Egyptian medical manual, the Ebers Papyrus, written about 1500 B.C.E. and compiled from works dating to 4000 B.C.E., contains a recipe for compounding tooth-cleaning preparations. 8
  • 9. Chinese • The Chinese described a powder to be used to prevent the progress of caries and also to whiten the teeth. • The major components were salt and musk. Ammonia, as a component of urine, was also added to the mixture to enhance its efficacy. 9
  • 10. Hippocrates • Hippocrates (460-377 B.C.E.) is generally considered the first to recommend the use of a dentifrice. • In his text De Morbis Mulierum, in a section dedicated to “Diseases of Women”, he describes the “Indian medicament” used to clean teeth and give a sweet smell to the breath. • Hippocrates advised that one should prepare the dentifrice by burning the head of one hare and three mice - after taking out the intestines of two of them, but removing neither the liver nor the kidney. 10
  • 11. Celsus • Celsus advised that one should rub the teeth with a mixture of pounded rose leaves, gallnuts and myrrh. • This mixture was advocated to remove stain from the teeth. • Myrrh would most likely act as a solvent for some stains and the powdered gall nuts as an abrasive. 11
  • 12. Romans • The Romans took great care of their teeth. • They washed them and rubbed them with wool and made dentifrices from burnt stag’s horn and the carbonized heads of hare, mice, and wolves, along with the burnt heels of oxen and goat’s feet. • Pounded egg shells, snail shells, and pumice powder were frequently mixed with myrrh. • The use of salt was also described by the Romans. 12
  • 13. • Pliny advocated use of the ashes of the head of a hare. He stated that any useful dentifrice could be improved by adding spikenard to lessen the bad smell of the mouth. • Carbonate of lime was thought to be effective and he described a method for its preparation: • “Egg shells should be deprived of their internal membrane and afterwards burnt to afford a good dentifrice”. • Scribonius Largus described a dentifrice made from barley flour mixed into a paste with vinegar and honey. 13
  • 14. • Avicenna, from Persia, was one of the early consumer advocates in dentifrice evaluation. • He advised his patients to avoid hard powders, as they were liable to injure the substance of the teeth. • He also noted the importance of remedies to remove tartar and suggested that burnt gypsum be used. • This bears a remarkable similarity to the pyrophosphate in use in the 20th century. 14
  • 15. • Al-Bayan, a Karaite Jew born in Cairo, published a treatise called “Hospital Formulary”. • One chapter is devoted to medicines for the mouth and dentifrices. • The dental pharmacotherapy was no more effective than the remainder of the medieval physician’s pharmacopoeia. • The basic active principles principles were astringents, germicidal agents and abrasives. • He described an arsenic tablet to be used for cavities and the foul odor of the gums and to remedy deterioration of the gums. 15
  • 16. • He also recommended a cooling agent to treat bleeding gums. • This contained flower of tamarisk, dry coriander, mauve seed and bamboo concretion. • Two dentifrices were recommended to polish teeth, strengthen the gums, and refine the odor of the breath. • In most cases, the mouth was to be rinsed with vinegar and rose water following the use of any of the dentifrices. • Apparently gingival recession was also known at that time, as Al- Bayan described a dentifrice to relieve pain in the teeth from cold. 16
  • 17. • In England of the 17th century, popular toothpowders contained ground china or earthenware, powdered coral, pumice, crab shells or cuttle bone and were probably applied with a cloth. • Charles Allen published a recipe for a dentifrice consisting of magistery (precipitate) of pearls, powder of coral, dragon’s blood, and red rose water, which he claimed was so good that it need only be used once a week. 17
  • 18. • The 18th century found a large number of products with greatly inflated claims. • In 1807, a London firm of chemists recommended the use of charcoal as a dentifrice. • Thomas Berdmore inveighed against vendors of destructive tooth powders and dentifrices and gave instructions to the public with the object of aiding them to distinguish good from bad. • In 1746 Pierre Fauchard stated that people who used opiates, powders and mouthwashes to clean and whiten teeth were dupes. 18
  • 19. • He noted that the chief ingredients of the products were brick dust, pumice, acid juices, spirit of vitriol and alum, all of which wore away the enamel and produced an indelible yellow stain on the teeth. • Fauchard described his own concoction, which he claimed would clean and whiten the teeth, strengthen the gums and never endanger the enamel. • He also noted that freshly emitted urine was the best mouthwash. 19
  • 20. • The American Colonies were no better. • In 1771, Michael Poree advertised “A composition for cleaning and preserving teeth and gums, likewise, a lotion, which is specific in all disorders of the mouth, eradicating every degree of the scurvy, preserving the teeth from decaying, and redoing them a very beautiful white and sound”. • In 1779, John Blake, described An anti-scorbutic dentifrice for preserving teeth and gums, quite free from any corrosive preparation. 20
  • 21. • B.T. Longbothom published a treatise on dentistry in 1802, and included a statement on “Improper Applications”. • Parmly thought that the tooth powders, tinctures and pastes that contained cream of tartar, alum, brick-dust, and charcoal, variously colored and scented, could injure the teeth. He wrote: • The best dentifrice that can be used, is common salt; it is perfectly innocent, as it completely dissolves in saliva, and produces all the friction necessary for cleansing the teeth. 21
  • 22. • David Wemyss Jobson of Edinburgh advised in 1834 that teeth should be scaled and then polished with a powder composed of equal parts of pulverized pumice stone and levigated chalk. • A Parisian dentist of the same era, J. Lefoulon, was among the first to advocate a pre-brushing rinse (with fresh tepid water). • After this, it is well to use some dentifrice powder, with which the teeth and gums should be well rubbed by a hard brush. 22
  • 23. • W. D. Miller ushered in a new era in the science of preventive dentistry. In 1890, he described his chemoparasitic theory of tooth decay. • Miller maintained that the exciting cause of dental caries was decalcification of the enamel by weak organic acids which created a boom in the toothpaste industry, with each manufacturer adding special agents or devoting his attention to separate phases of the problem. • The industry underwent a great change to constituents with an alkaline base. 23
  • 24. • Sodium bicarbonate and salt, separately or in combination, have been used widely as dentifrices, their use preceding the introduction of modern toothpaste. • In Europe as early as 1905, Carlsbad salt, consisting of a mixture of potassium sulfate, sodium chloride, sodium bicarbonate and sodium sulfate, was recommended for therapy of “alveolar pyorrhea”, to be introduced into gingival pockets after removal of deposits. 24
  • 25. • In 1916, Herrick, an American physician, proposed that a saturated solution of sodium bicarbonate be used to cleanse the mouth before retiring. • In the event of inflammation the powder was to be rubbed on the gums. • Procter and Gamble, concerned that the competition was succeeding with whitening products, attracted attention to the dangers of abrasion by marketing a nonabrasive liquid dentifrice, Teal@. 25
  • 26. • It failed, allegedly because many users developed unsightly brown pellicle stain. • After World War II, many dental companies undertook scientific studies to establish a therapeutic rationale for using any dentifrice. • Colgate advertised their “Dental Creme” and advocated brushing after meals. 26
  • 27. • At approximately the same time, active ingredients were placed in some dentifrices. The first to appear were urea and dibasic ammonium phosphate (1949). • Some of the ammoniated formulations were found to cause gingival inflammation. • Chlorophyll-containing dentifrices entered the scene and implanted the word “bad breath”. 27
  • 28. • Colgate marketed a sodium N-lauryl sarcosinate dentifrice and the role of enzymes and enzyme inhibitors in promoting and preventing dental caries became public knowledge. [Gardol@ invisible shield! (patented in 1954)]. • Crest@ entered the market in 1955. This stannous fluoride dentifrice is generally acknowledged to have ushered in the modern era of therapeutic dentifrices. • However, it was not until 1960 that the American Dental Association allowed its Council on Dental Therapeutics to grant a seal of provisional approval to dentifrices. 28
  • 30. • Function is described as follows 1) Cosmetic 2) Cosmetic – therapeutic 3) Therapeutic 30
  • 31. Cosmetic • Not containing a drug substance. • Used for routine, nonspecific manner in an attempt to remove materials like material alba, film (pellicle and plaque), food debris, and stain from tooth surfaces. • Net effect- cosmetically clean and healthy dentition and a fresher breath. 31
  • 32. Cosmetic – therapeutic • Cosmetic effect • Therapeutic effect- effect upon the incidence of caries, calculus, and gingival disease. 32
  • 33. Therapeutic • Contain a drug substance • Net effect- providing of the specific chemical or pharmalogic action of drug substance, as manifested clinically by a reduction in the incidence of caries, calculus, and gingival disease. 33
  • 35. COMPOSITION OF DENTIFRICES Ingredients N O Harris (%) Stallard (%) Melberg (%) SS HIREMATH (%) Abrasives 20-40 20-40 40-50 20-50 Water 20-40 15-50 20-30 - Humectants 20-40 20-40 20-40 20-40 Foaming agent (soap or detergent) 1-2 Upto 2 1-2 1-3 Binding agent Upto 2 - 0.5-2 1-3 Flavouring agent Upto 2 - 1-4 1-2 Sweetening agent Upto 2 - - 1-2 Therapeutic agent Upto 5 Upto 2 - 0.4-1 Colouring or preservative Less than 1 Upto 2 (colours, preservatives, sweeteners, stabilizers) - <1 35
  • 36. Abrasive system (Cleaning and polishing agent) • Substance that clean or polish the tooth surfaces are commonly referred to as abrasives. • Abrasivity must be sufficient to remove and prevent the buildup of stain, but mild enough so that the enamel or exposed root surfaces are not harmed. Purpose 1) To remove debris, stain, and plaque from tooth surfaces. 2) To polish or impart a lustre to the tooth surfaces. 36
  • 37. • The most important factors in selecting a particular abrasive for a fluoride-containing dentifrice are its degree of abrasivity to dental hard tissue and its compatability with fluoride. • The degree of dentifrice abrasiveness depends on the inherent hardness of the abrasive, size of the abrasive particle, and the shape of the particle. • Several other variables can affect the abrasive potential of the dentifrice: the brushing technique, the pressure on the brush, the hardness of the bristles, the direction of the strokes, and the number of strokes. 37
  • 38. • The abrasive tested alone can differ from the same abrasive tested as part of a dentifrice formula. • The salivary characteristics of individuals may also affect dentifrice abrasiveness. 38
  • 39. Various abrasives used Insoluble sodium metaphosphate, (NaP03)x Calcium pyrophosphate, Ca2P207 Dicalcium phosphate dihydrate, CaHP04-2H20 Dicalcium phosphate anhydrous, CaHP04 Calcium carbonate (chalk), CaC03 Alumina trihydrate, AI203-3H20 Silica, Si02 Sodium bicarbonate, NaHC03 Plastic particles. Polymethylmethacrylate 39
  • 40. • Abrasives usually do not damage enamel, but they may dull the tooth luster. • To compensate - polishing agents are added to the dentifrice formulation. (small-sized particles of aluminum, calcium, tin, magnesium, or zirconium compounds) • Typically, the manufacturer blends the abrasives and the polishing agents to form an abrasive system. 40
  • 41. • Agents, such as chalk or silica, may have both polishing and abrasive effects. Smaller particles (1 mm) - polishing action larger particles (20 mm) - abrasive action. 41
  • 42. Selection of dentifrices with abrasives • Population does not accumulate visible stain when engaged in their own style of personal oral hygiene - a dentifrice with high polishing and low abrasion should be recommended. • For the average individual, an additional amount of abrasive is needed to control accumulating stain. • As the abrasive level increases, greater care must be taken to perfect brushing techniques that do not cause self-inflicted injury to the teeth or soft tissues. 42
  • 43. 43
  • 44. 44
  • 45. 45
  • 46. Humectants • Primary function is to retain moisture and thus provide for a paste that is chemically and physically stable. • Toothpaste consisting only of a toothpowder and water results in a product with several undesirable properties. • Over time, the solids in the paste tend to settle out of solution and the water evaporates. This may result in caking of the remaining dentifrice. • Until the 1930s, most toothpaste had a short shelf-life because of this problem. Once the tube was opened, the first expelled paste was too liquid, but the last paste in the tube was either impossible to expel or too hard to use. 46
  • 47. • To solve this problem, humectants were added to maintain the moisture. • Commonly used humectants are sorbitol, mannitol, and propylene glycol. • These humectants are nontoxic, but mold or bacterial growth can occur in their presence. • For this reason, preservatives such as sodium benzoate are added. 47
  • 48. • Humectants help maintain the consistency of toothpaste, but despite their presence, the solids tend to settle out of the paste. • To counteract this, thickening or binding agents are added to the formula. • At high concentrations (>40%), humectants also act as preservatives. 48
  • 49. Binding agent • The binding or thickening, agent in the dentifrice holds the abrasive in suspension. • In general all binding agents are hydrophilic colloids that appear to dissolve in water but actually disperse and swell to form viscous liquid phases. • Commonly used binding agents are sodium alginate, irish moss extract, cellulose derivatives (eg metyl cellulose and carboxymethylcellulose), and inorganic clay like materials such as colloidal magnesium aluminium silicate. 49
  • 50. Soaps and Detergents • Detergents are surface active cleaning agent that • lower surface tension, • penetrate and loosen deposits • suspend debris • aid in dispersing the dentifrice and its fluoride component throughout the mouth. 50
  • 51. • Because toothpastes were originally manufactured to keep the teeth clean, soap was the logical cleansing agent. • Soaps have several disadvantages: • they can be irritating to the mucous membrane (relatively high alkaline pH), • their flavor is difficult to mask, and often causes nausea, and • many times soaps are incompatible with other ingredients, such as calcium. 51
  • 52. • When detergents appeared on the market, soaps largely disappeared from dentifrices. • Various detergents used are sodium lauryl sulfate (SLS), sodium N- lauroyl sarcosinate, Sodium cocomonoglyceride sulfonate. • SLS is active at a neutral pH, has a flavor that is easy to mask, and is compatible with the current dentifrice ingredients. 52
  • 53. • Barkvoll has suggested that patients who suffer from various oral mucosal diseases should avoid the use of dentifrices containing SLS. • Low SLS dentifrices have been marketed, which claim to be associated with a lower incidence of oral ulcers. 53
  • 54. Flavoring Agents • Flavor, along with smell, color, and consistency of a product, are important characteristics that lead to public acceptance of a dentifrice. • If dentifrices did not possess these characteristics, they would probably be poorly accepted. • For taste acceptance, the flavor must be pleasant, provide an immediate taste sensation, and be relatively long-lasting. 54
  • 55. • Usually synthetic flavors are blended to provide the desired taste. Spearmint, peppermint, wintergreen, cinnamon, and other flavors give toothpaste a pleasant taste, aroma, and refreshing aftertaste. • Some manufacturers use essential oils such as thymol, menthol, etc., which may provide a "medicinal" taste to the product. In addition, these oils may impart antibacterial effects. 55
  • 56. Sweetening Agents • In early toothpaste formulations, sugar, honey, and other sweeteners were used. • Because these materials can be broken down in the mouth to produce acids and lower plaque pH, they may increase caries. • They have been replaced with saccharin, cyclamate, sorbitol, and mannitol, xylitol as primary noncariogenic sweetening agents. • Sorbitol and mannitol serve a dual role as sweetening agents and humectants. 56
  • 57. Miscellaneous ingredients • Tube corrosion inhibitors- sodium silicate • Approved food colours • Traces of titanium dioxide, which is used as whitening agent. 57
  • 58. Other Physical forms • Toothpowders contain essentially the same ingredients as toothpaste, with the exception of water, humectants, or binders. • Their capacity to clean or polish teeth (abrasivity) would depend, to a great extent, on the degree of dilution (essentially water) that is used with them. 58
  • 59. • Liquid dentifrices, such as some “ tooth polishers” also contain ingredients similar to those in toothpaste. • They have lesser amount of binders and thus flow more freely. • Some are formulated without detergents (lack foaming characteristics). • In general, it may not be sufficiently abrasive to maintain tooth cleanliness, especially if they do not contain conventional quantities of cleaning and polishing agents. 59
  • 62. 1.1. Fluoride concentration upto 1000 ppm • In the 1980’s, several studies were carried out which showed that children 2-5 years old swallow 30- 50% of the toothpaste applied to a toothbrush. • These studies were followed by research about the correlation between the fluoride concentration in toothpastes and the spread of fluorosis in permanent teeth. • As a result, due to the risk of fluorosis, it was recommended that children use toothpastes with a fluoride concentration of 500-550 ppm. 62
  • 63. 63
  • 64. 64
  • 65. • Further it is proven that toothpastes with fluoride concentrations of 400-550 ppm do not differ from placebo toothpastes. • Few studies with (1000-1500 ppm) showed prevalence of fluorosis, but the severity was very mild, and caused neither clinical, nor aesthetic problems. • There is also evidence that when using 400 ppm or 1450 ppm toothpastes from 1 year of age, but in strict compliance with the "pea size" amount of toothpaste on a toothbrush, the prevalence of aesthetically noticeable fluorosis does not differ between the two groups. 65
  • 66. 1.2. Fluoride concentration 1000-1500 ppm • The ability of toothpastes to reduce caries cited in literature varies from 19-27% , however toothpaste with 1000 to 1500 ppm concentrations is recognized as the most effective fluoride source. • Children from 2-3 years of age swallow 48% of toothpaste, but children from 6-7 years of age swallow 25% of toothpaste. • In order to reduce the risk of fluorosis, children use toothpastes with fluoride concentration of 1000 ppm, taking in account the age- appropriate amount. 66
  • 67. 1.3. Fluoride concentration 2500-5000 ppm • Higher concentrations in toothpastes can achieve a caries reduction of up to 36%. • In vitro studies also show that toothpastes with elevated concentrations have a higher ability to remineralize enamel and dentin better than toothpastes with normal concentrations or placebo toothpastes. 67
  • 68. Therapeutic Dentifrices • The most commonly used therapeutic agent added to dentifrices is fluoride, which aids in the control of caries. • In 1960, the Council on Dental Therapeutics of the American Dental Association - Crest toothpaste with stannous fluoride as a caries prophylactic dentifrice (a therapeutic dentifrice was awarded the Seal of Provisional Acceptance) 68
  • 69. • The original level of fluoride in OTC dentifrices and gels was restricted to 1,000 to 1,100 ppm fluoride and a total of no more than 120 mg of fluoride in the tube, with a requirement that the package include a safety closure. • Therapeutic toothpastes, dispensed on prescription, could contain up to 260 mg of fluoride in a tube. 69
  • 70. • The following fluorides are generally recognized as effective and safe for OTC sales: • 0.22% sodium fluoride (NaF) at a level of 1,100 ppm, • 0.76% sodium monofluorophosphate (MFP) at a level of 1,000 ppm • 0.4% stannous fluoride (SnF2) at a level of 1,000 ppm. 70
  • 71. • Fluoride levels were increased to 1,500 ppm sodium monofluorophosphate in "Extra Strength Aim," marketed OTC (10% more effective than an 1,100 ppm NaF dentifrice) • Colgate Prevident 5,000, contains 5,000 ppm fluoride. • One baking soda-peroxide-fluoride dentifrice (Mentadent). Mentadent contains a combination of 0.75% stable peroxide gel in conjunction with baking soda, and 1,100 ppm sodium fluoride. 71
  • 73. Fluoride compounds 1. Inorganic fluorides • Sodium fluoride • Sodium monofluorophosphate • Stannous fluoride • Potassium fluoride • Aluminium fluoride 73
  • 74. 2. Organic fluorides • Amine fluoride (Hetaflur) • Amine fluoride (Olaflur) 3. Combinations of fluorides • Amine fluoride + Sodium monofluorophosphate • Amine fluoride + Sodium fluoride • Sodium fluoride + Sodium monofluorophosphate 74
  • 75. 75
  • 76. 76
  • 77. Sodium fluoride toothpastes • From1945-1985 – Toothpastes with sodium fluoride have been compared with placebo pastes. • The first four studies (1945-1961) used toothpastes in which the abrasive component of the toothpaste was calcium carbonate or calcium orthophosphate, or sodium meta-phosphate. • None of these studies showed a caries reducing effect of the products tested. 77
  • 78. • In 1961, Ericsson – in products containing calcium salts the fluoride from the highly soluble sodium fluoride reacts to produce insoluble calcium fluoride. • Torrel & Ericsson (1965) – replaced conventional calcium-based abrasive was replaced by an inert abrasive (sodium bicarbonate). • Found Statistically significant reduction in caries increment over a 2- year period.(18%) • With insoluble sodium metaphosphate- caries inhibition of 9-48% • With calcium pyrophosphate- caries inhibition of 11-38% • 62% of trials reported= 11-30% reduction. 78
  • 79. Stannous fluoride toothpastes • There are more reported trials of stannous fluoride toothpastes than of any of the other fluoride salts. • Use and promotion of these toothpastes preceded sodium fluoride by some 10 years as the first trial reported in 1955 found a sensational 49% reduction in caries increment. • As a result of trials Council on Dental Therapeutics of the ADA first awarded complete acceptance to a fluoride dentifrice, specifically the stannous fluoride- calcium pyrophosphate formulation (Crest), in 1964. 79
  • 80. Out of 47 studies 34 studies were with calcium pyrophosphate as abrasive.  Most of the results were positive, with 61% of the trials reporting caries inhibition of 11-30% 12 studies with insoluble sodium metaphosphate,  5 compared calcium pyrophosphate with insoluble sodium metaphosphate, although the difference was not significant.  1 study with stannous fluoride-silica abrasive system reported 15% caries inhibition over a 3 year period. 80
  • 81. • However, the results of later clinical trials have not consistently demonstrated statistical significance. • The explanation for this may lie in the instability of the stannous fluoride salt which is subject to hydrolysis with time, resulting in for- mation of a variety of complex ions. • Stannous fluoride toothpastes have now more or less been abandoned not only because of the inconsistency of trial results but also because a marked disadvantage was that these toothpastes caused brown staining of the teeth. 81
  • 82. Sodium monofluorophosphate toothpastes • Twenty-one trials reported during the period 1963-1983, have shown the benefits of using a monofluorophosphate toothpaste compared with a placebo. • The background for using this compound was twofold. 1. Monofluorophosphate had been successfully used in topical fluoride solutions. The phosphate ion was considered important for this purpose. 2. The results of in vitro studies which showed that this salt could be used with calcium carbonate and other abrasives not compatible with sodium fluoride. 82
  • 83. • Although insoluble sodium metaphosphate has been the most commonly used abrasive. • Others like calcium carbonate, calcium pyrophosphate, silica and alumina trihydrate has also been used. • 71% of the clinical trials found caries inhibition of 11-30% & • 50% were between 21-30%. • 3 clinical trials compared SnF with MFP and found that MFP is slightly more effective than SnF toothpastes. 83
  • 84. • The first product, Colgate MFP, used insoluble sodium metaphosphate as the abrasive system, and this formulation was shown to reduce the incidence of caries in children by as much as 34%. • On the basis of these studies, this dentifrice was approved as safe and effective by the FDA in 1967 and accepted by the ADA in 1969. 84
  • 85. Amine-fluoride toothpastes • The philosophy behind using an organic fluoride compound in a toothpaste was based on studies which suggested that uptake of fluoride in enamel could be enhanced by using a substance with affinity for the enamel surface. • Also, in vitro studies had demonstrated that amine fluorides could reduce enamel solubility and retard enzyme activity in plaque. 85
  • 86. • Only few trials have been reported. • The results were encouraging but the last trial conducted in USA gave negative results and possible toxicity of the compound has been questioned. 86
  • 87. Comparison of NaF and MFP toothpaste • Subsequent literature reviews compared all available clinical data regarding the relative efficacy of compatible sodium fluoride dentifrices and those containing sodium monofluorophosphate. • Using different statistical procedures, these reviews concluded that sodium fluoride was significantly more effective than sodium monofluorophosphate. • Based on a meta-analysis, it was concluded that the magnitude of this difference was 7%. 87
  • 88. • It is interesting that many fluoride dentifrices contain mixtures of sodium fluoride and sodium monofluorophosphate with a total fluoride content of 1,500 ppm. • Clinical efficacy data of these latter systems have also been reviewed with the conclusion that they are numerically less effective than an equivalent concentration of bioavailable sodium fluoride. 88
  • 89. Other fluoride dentifrices • Dentifrice containing 0.125% fluoride, provided by 1 diethanol aminoprpphyl-N-ethanol octa-decylamine- dihydrofluoride 2. cetylamine hydrofluoride 89
  • 90. Fluoride abrasive compatibility • Of major importance to fluoride containing dentifrices is the compatibility of the abrasive with the fluoride source. • Inactivation can occur through reactions forming calcium fluoride or Fluorapatite, by adsorption to the abrasive surface, or by complexing with soluble ions. • The compatibility of calcium-containing abrasives has been improved by modification of their chemical and physical forms. 90
  • 92. Fluoride toothpaste and oral clearance • Chesters et al. (1992) drew attention to the fact that the method of oral rinsing after using F-toothpaste, and the frequency of toothbrushing, can both have a relationship with caries increments in clinical trials. • The DMFs increment in this study was highest (6.9) when a beaker was used to rinse away toothpaste followed by ‘using a brush’ (5.9), putting ‘head under tap’ (5.8) and ‘using hand’ (5.5.). • The caries increment for those who brushed once per day or less was higher (7.0) than those who brushed twice per day or more (5.4). 92
  • 93. • From these results it may be concluded that the greatest reduction in DMFs increment occurs when brushing at least twice per day and rinsing by means of hand under the tap. • Similar findings have been reported by Ashley et al. 1999. 93
  • 94. 94
  • 95. Fluoride dentifrices and dental fluorosis • Several reports have indicated an increasing prevalence of fluorosis in the United States by the use of fluoride dentifrices. • A national survey of U.S. children conducted between 1986 and 1987 indicated that about 22% displayed some evidence of dental fluorosis; however, it is important to note that, in terms of severity, a majority had either very mild or mild fluorosis, and only about 1% were classified as moderate or severe. 95
  • 96. • These considerations have prompted the ADA to recommend that children under age 3 should be advised to use only a "pea-sized" quantity of a fluoride dentifrice for brushing and that this quantity be gradually increased with age so that not until age 6 is the child using a "full-strip" of dentifrice on the brush head. • Using no more than a ‘smear’ or ‘rice-size’ amount of fluoridated toothpaste for children less than three years of age may decrease risk of fluorosis. Using no more than a ‘pea-size’ amount of fluoridated toothpaste is appropriate for children aged three to six. (AAPD 2014) 96
  • 98. Chlorophyll containing dentifrices • Water soluble derivatives of chlorophyll are used. • Use is based on the ability of chlorophyll to reduce bacterial growth and to reduce acid formed in dental plaque. • Specific compound utilized is – sodium copper chlorophyllin. • Only animal studies • Out of 4, only 1 study showed benefit against gingival disease. • Currently not accepted by ADA. 98
  • 99. Antibiotic containing dentifrices • Based on premise to destroy or inactivate the microorganisms that are associated with oral disease. • Studies have been conducted with toothpowders containing penicillin and erythrocin containing dentifrices. • Out of 6, four studies showed decrease in caries incidence. • However FDA opposed the regular use of antibiotics due to several reasons. 99
  • 100. Ammonium containing dentifrices • Urea and dibasic ammonium phosphate have been used in dentifrices. • Based on theory that ammonia and urea can neutralize the acid produced by acidogenic bacteria in dental plaque. • Also urea could function as an enzyme inhibitor by virtue of its protein denaturant properties. • Studies have shown positive results for caries reduction. However ADA has not recommended urea or ammonium compound as active ingredients in dentifrices. 100
  • 101. Enzyme inhibitor containing dentifrices • Theory was suggested that dental plaque might serve as medium for the retention of enzyme inhibitor on the tooth surface, where they would be available to prevent the enzymatic conversion of sugar into acid. • Few formulations have been used are • 2% sodium N-lauroyl sarcosinate • 0.75% sodium dehydroacetate • 0.5% sodium oxalate 101
  • 102. • ADA has indicated that evidence in support of antienzyme dentifrices is controversial and that usefulness of these dentifrices in caries control has not been adequately established. 102
  • 103. Baking-Soda Dentifrices • Baking soda (sodium bicarbonate) has had a long history of use as an oral-hygiene aid. • In a series of papers published in 1998, antiplaque, gingivitis reduction, stain-removal, and odor-reducing efficacy were documented for sodium bicarbonate-containing dentifrices. • Some dentists have also suggested the mixture of baking soda with peroxide as an alternative to the use of commercial dentifrices. 103
  • 104. • No dentifrice containing baking soda as the sole active ingredient has received the ADA Seal of Acceptance. • It was only after fluoride was added to the formulations, and after required laboratory, animal, and clinical studies were completed, that several baking soda-fluoride dentifrices were accepted as effective in caries control. • These baking-soda dentifrices actually contain only a small amount of baking soda, in addition to the standard fluoride-compatible abrasives. 104
  • 105. Essential-Oil Dentifrices • The essential-oil ingredients found in Listerine mouthrinse are also available in a dentifrice formulation. • The clinical and laboratory data suggest a benefit to gingival health and plaque reduction. • This product does not carry the ADA Seal of Acceptance. 105
  • 106. Anticalculus Dentifrices • Calculus-control dentifrice formulations are designed to interrupt the process of mineralization of plaque to calculus. • Crystal growth inhibitors may be added to dentifrices to provide a reduction in calculus formation. • In the late 1970s, anticalculus dentifrices began to appear on the market without any evidence of effectiveness. 106
  • 107. • In 1985, Procter & Gamble supplemented their existent Crest anticariogenic toothpaste with a similar anticaries formula that also contained a combination of tetra sodium phosphate and disodium dihydrogen pyrophosphate (crystal growth inhibitors). (Crest Tartar Control) • This combination has been demonstrated in clinical studies to significantly reduce the amount of calculus formed, compared with a control dentifrice. 107
  • 108. • The formula received the American Dental Association's Seal of Acceptance, but only as a caries control product and only because of its fluoride content. • Other similar anticalculus products that are now on the market all contain NaF. 108
  • 109. • Rolla and Saxegaard have noted the possibility of "crystal poisons," such as pyrophosphates and phosphonates, inhibiting remineralization. Such inhibition might adversely affect the anticaries effect of the fluoride in this type of calculus control dentifrice. • Zinc citrate trihydrate is used to inhibit calculus formation in the tartar control versions of both Aim and Close-Up. Clinical studies have shown that zinc citrate does not affect the caries inhibition of fluoride. 109
  • 110. • Despite favorable anticalculus data, the ADA seal has not been awarded to products with only an anticalculus claim, because the ADA considers calculus inhibition as a cosmetic, not a therapeutic effect. • With an anticalculus agent, two simultaneous beneficial effects caries control and calculus inhibition are available with one brushing operation. 110
  • 111. Antihypersensitivity Products • Several OTC dentifrices have been accepted with the active agents such as potassium nitrate, strontium chloride, and sodium citrate. • These therapeutic dentifrice are directed simultaneously at solving two problems, caries and hypersensitivity, with the same brushing operation. 111
  • 112. Analgesic toothpastes • Toothpastes containing potassium saline maintain a high K+ extracellular level, thus preventing re-polarization of the nerve cell membrane and inhibiting the transmission of impulse. • Based on studies, improvement was observed in 85% of the cases. Toothpaste, which is composed of 5% or 10% potassium nitrate, can decrease tooth sensitivity for up to 4 weeks. • However the authors of the Cochrane systematic review do not find sufficient evidence of the clinical efficacy of potassium salts in the reduction of dentin hypersensitivity 112
  • 113. Dentin tubule blocking toothpastes • Stannous fluoride possesses the ability to block tubules, forming SnF2 and CaF2, and the ability to form a protective layer on the tooth surface, by creating a reaction of Sn2+ ion with sodium, calcium and phosphate compounds and forming Sn-Na hexametaphosphate. • In addition, by adding calcium and phosphate ions, they combine with the fluoride ions on the enamel surface and form an amorphous calcium phosphate, which in addition to blocking tubules, also smoothes the tooth surface, achieving an even more effective reduction of sensitivity. 113
  • 114. • Toothpastes containing arginine also yield good results in the reduction of dentin hypersensitivity they can block the dentin tubules. • In several studies it has been proven that the clinical hyposensitive effect of arginine is greater than that of potassium salts and fluoride. • Based on recent systematic review the arginine/calcium carbonate- based toothpaste provided a higher level of efficacy in terms of DH relief than the strontium-based toothpaste. 114
  • 115. 115
  • 116. 116 American Journal of Dentistry, Vol. 23, Sp. Is. A, May, 2010
  • 117. 117 American Journal of Dentistry, Vol. 23, Sp. Is. A, May, 2010
  • 118. Lead tube to Plastic Packaging • The change to plastic packaging during World War II simultaneously: • Eliminated the possibility of the user ingesting lead, • Reduced the possibility of incompatibility of the tube and paste components, • Aided the expelling of the paste by squeezing, • Permitted an easier and more economic production of tubes, and • Provided a good surface for the printing of decorative designs and information. 118
  • 119. Risk for fluorosis • Use of a pea-sized amount (approximately 0.25 g) of fluoride toothpaste <2 times per day by children aged <6 years is reported to sharply reduce the importance of fluoride toothpaste as a risk factor for enamel fluorosis. • Since 1991, manufacturers of fluoride toothpaste marketed in the United States have, as a requirement for obtaining the ADA Seal of Acceptance, placed instructions on the package label stating that children aged <6 years should use only this amount of toothpaste. 119 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5014a1.htm
  • 120. Fluoridated dentifrice for children • Toothpaste labeling requirements mandated by FDA in 1996 also direct parents of children aged <2 years to seek advice from a dentist or physician before introducing their child to fluoride toothpaste. 120 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5014a1.htm
  • 121. • Fluoride Toothpaste • Fluoride toothpaste is widely available, no more expensive than nonfluoride toothpaste, and periodically improved. • Use of a pea-sized amount (0.25 g) twice per day requires approximately two tubes of toothpaste per year, for an estimated annual cost of $6--$12, depending on brand, tube size, and retail source. 121
  • 122. 122
  • 123. 123
  • 124. Whiteners • These dentifrices control stain via physical methods (abrasives) and chemical mechanisms (surface active agents or bleaching/oxidizing agents). • Although the public perceives these as more abrasive than ordinary toothpastes, their abrasiveness is usually intermediate among the products tested. • Dentifrices marketed with tooth-whitener claims are available as a toothpaste or gel, or are used in a two- or three-step treatment "process." 124
  • 125. • These products usually contain hydrogen peroxide or carbamide peroxide as their bleaching or whitening ingredient. • Carbamide peroxide breaks down to form urea and hydrogen peroxide. • Hydrogen peroxide, in turn, forms a free radical containing oxygen, which is the active bleaching molecule. • Home-bleaching products may contain other chemicals to aid in the delivery of the bleaching agent. 125
  • 126. • Glycerin or propylene glycol is commonly added to thicken the solution and prolong contact with the tooth surface. • In the two- or three-step products, agents can be delivered to teeth via a custom-made tray or by toothbrushing. • Side-effects includes, overgrowth of undesirable organisms, including yeasts, possibly leading to "black hairy tongue, damage the pulp or the soft tissues of the mouth, delayed wound healing. 126
  • 127. • The Food and Drug Administration has classified these products as drugs. • The American Dental Association's Council on Scientific Affairs has issued "Guidelines for the Acceptance of Peroxide Containing Oral Hygiene Products." 127
  • 128. Antiplaque and AntigingivitisToothpastes • Term antiplaque refers more often to agents capable of significantly reducing plaque levels and antigingivitis to agents capable of significantly reducing gingivitis levels. • Antiplaque activity may be achieved by different mechanisms of action: (a) by preventing bacterial adhesion; (b) by limiting bacterial growth and/or coaggregation; (c) by disrupting an already established biofilm; (d) by altering the composition and/or pathogenicity of the biofilm 128
  • 129. Composition Enzymes • Specific agents include glucose oxidase and amyloglucosidase. • Their mechanisms of action rely on the catalyzation of thiocyanate into hypothiocyanite through the salivary lactoperoxidase system. Amine Alcohols • Specific agents include delmopinol and octapinol. Their mechanism of action is through the inhibition and disruption of the biofilm extracellular matrix, and therefore they are not antimicrobial agents since they disrupt an already established biofilm. • They also inhibit glycan synthesis by Streptococcus mutans and thus reduce bacteria acid production. 129
  • 130. Metal Salts: Zinc Salts • Specific agents include zinc lactate, zinc citrate, zinc sulphate or zinc chloride. • Zinc salts have shown antibacterial action due to their ability to inhibit bacterial adhesion, metabolic activity and growth. • Zinc products have been evaluated for plaque control, but also focused on halitosis control, or healing properties in presence of ulcers 130
  • 131. Metal Salts: Stannous Fluoride • Stannous fluoride has been included in dentifrices and gels since 1940s. • The mechanism of action of the stannous ion is through adherence to the bacterial surface, inhibition of bacterial colonization, penetration into the bacteria cytoplasm and interference with the bacterial metabolism. 131
  • 132. Natural Products • Specific agents include sanguinarine extract and other herbal ingredients (chamomile, echinacea, sage, myrrh, rhatany, peppermint oil). Triclosan • Triclosan [5-chloro-2-(2, 4 dichlorophenoxy) phenol] is a non-ionic bisphenolic, broad-spectrum antibacterial agent. • Triclosan has been widely formulated in dentifrices usually in combination with polyvinyl-methyl ether maleic acid copolymer, zinc citrate or pyrophosphate, in order to improve the substantivity and/or the antimicrobial activity. 132
  • 133. • Triclosan has also demonstrated anti-inflammatory effects through the inhibition of the cyclooxygenase and lipoxygenase pathways, by reducing the synthesis of prostaglandins and leukotrienes. Bisbiguanides: Chlorhexidine • CHX is an active agent against Gram-positive and Gram-negative bacteria, yeasts and viruses. 133
  • 134. Quaternary Ammonium Compounds • Specific agents include benzylconium chloride and Cetylpyridinium chloride (CPC). • Their mechanisms of action rely on the hydrophilic part of the CPC molecule that interacts with the bacterial cell membrane, leading to its disruption, alteration of the bacterial cell metabolism growth inhibition and finally cell death. 134
  • 135. Dentifrices with specialized function • It was supplied by Dr. Ira L. Shannon, a dental consultant to Johnson Space Center associated with the Oral Disease Research Laboratory of the Veterans Administration Hospital in Houston. • Developed in response to the specific needs of astronauts while in space missions. • This ingestible dentifrice, designed to assist in maintaining oral hygiene during prolonged periods of chamber confinement. 135
  • 136. • It was formulated within the following limitations 1) no volatile oils 2) no detergent (or foaming agent) 3) low calcium content 136
  • 137. Ingestible dentifrice contains the following ingredients • Insoluble sodium metaphosphate(40%) • Dicalcium phosphate dehydrate(2.6%) • Glycerine (32%) • Carboxymethylcellulose (1.3%) • Saccharin (0.1%) • Distilled water (24%) 137
  • 138. • Comparison tests with a commercially available dentifrice showed that there was no significant difference in the cleaning ability and user acceptance of the two types of toothpaste. • Applied without water, the pleasantly-flavored ingestible toothpaste has been used for years by astronauts in space and on Earth. • Important aid to maintaining oral hygiene among patients in hospitals, nursing homes and other special care facilities 138
  • 139. • It also offers major benefit to certain categories of patients, such as those bed-confined in hospital wards who might not have facilities for expectoration; paraplegics confined to wheelchairs; patients with oral-facial paralysis whose ability to expectorate is limited; the mentally handicapped; and others whose illness require that attendants carry out the tccthbrushing for them. 139
  • 140. Herbal Dentifrices • Herbal toothpastes, at least the ones on retail shelves in India, cater to the demand of consumers who want ‘natural’ alternatives to chemical-based products. • there is not much difference in the texture or consistency of the herbal toothpastes when compared to conventional toothpastes, and are different mainly in colour and flavour. • Most herbal toothpastes do not look pristine white, but have a range of colours and also tend to taste rawer and less sweet. 140
  • 141. • However, herbal toothpastes should ideally not contain any unnatural chemical, dyes or artificial flavours and preservatives, and should be made with only natural ingredients. Unfortunately, no brand in India can claim to be that ‘natural’. • No ‘significant’ difference exist between regular toothpastes and the herbal ones. 141
  • 142. • Ordinary or regular (non-herbal) toothpaste includes abrasives or excipient (calcium carbonate and silica), foaming agents (surfactants), anti-cavities fluoridation, flavouring agents and sweetening agents (sodium saccharin). • These ingredients form over 90 per cent of the paste and the rest 10 per cent is generally those added flavours or other agents that become differentiation elements and also help in creating a unique selling proposition (USP) that brands talk about in their marketing messages. • When this 10 per cent element also includes 2.5 per cent of herbal extracts or Ayurvedic elements, the paste becomes herbal – in any case, that is what a consumer is made to believe. 142
  • 143. 143
  • 144. Factors Affecting Dentifrice Effectiveness • In addition to the inherent properties of a fluoride dentifrice product, biological and behavioral factors can modify its anticaries effectiveness. • All of these factors interplay in what can be described as the "application" phase (the initial interaction of relatively high concentrations of fluoride with the tooth surface and plaque), and the "retention“ phase (the fluoride remaining in the mouth after brushing that is retained in saliva, plaque and plaque fluid, the tooth surface, and oral soft tissue reservoirs). 144
  • 145. • Behavioral factors include the frequency of dentifrice use, length of brushing, rinsing practices after brushing, the time of day that dentifrice is applied, and amount of dentifrice applied to the brush. • It is well established that the frequency of use has a major influence on effectiveness. • Bushing twice per day or more has a greater preventive effect than once per day. 145
  • 146. • Length of the brushing time (application phase) determines how long the relatively high fluoride concentration in the dentifrice slurry stays in contact with the teeth and plaque, allowing fluoride uptake to take place. • The higher the fluoride concentration, the greater the driving force for fluoride diffusion through plaque toward the tooth surface. • Rinsing behaviors after toothbrushing affect the amount of fluoride retained in the mouth and have been reported to affect caries experience. 146
  • 147. • Physiologic (biological) factors, mainly salivary flow rate during and after fluoride application influence the rate of fluoride clearance. • Bedtime use of fluoride dentifrice results in longer fluoride retention than daytime application due to greatly decrease salivary flow during sleep. • The amount of fluoride applied to the toothbrush (dose) is not as important as the concentration of available fluoride in a dentifrice. 147
  • 148. DENTRIFICES AND THE ORAL TISSUES 148
  • 149. Effect on mucosa • Every commercially available dentifrice has been reported to be associated with some type of reaction. (i.e particular type of reaction in particular person) • But the incidence of mucosal reactions are relatively small. • Allergic reactions and contact dermatitis caused by the ingredients in toothpaste have been reported. • Some studies have documented allergic reactions to the flavorings used, especially cinnamic aldehyde. • Others have reported skin reactions to the preservatives, especially sodium benzoate, and to aluminum. 149
  • 150. • Still others have shown contact dermatitis caused by sodium lauryl sulfate and propylene glycol. • Dentist can advice the person to discontinue the particular dentifrice and use another brand, if it is associated with mucosal reaction. • If the person continues to experience the reaction with a new product, then a more generalized allergic- type response should be suspected. • The person should be referred to a dermatologist for further evaluation and examination. 150
  • 151. Monitoring the Safety and Effectiveness of Therapeutic Dental Products • There are three levels of regulation of oral chemotherapeutic agents. The government level includes the Food and Drug Administration (FDA) and the United States Pharmacopoeia Convention. • The professional or voluntary level includes the Council on Scientific Affairs (CSA) of the American Dental Association (ADA). • The third level of review includes consumer advocacy organizations, advertising standards review panels, and the Federal Trade Commission 151
  • 152. • The stages of FDA approval include preclinical research and development (animal testing, laboratory testing, and toxicity evaluation) • Clinical research conducted with an approved investigational new drug (IND) application. (Three phases) • After the company receives an approved new drug application (NDA), marketing may begin, but post-marketing surveillance of the product is mandatory. 152
  • 153. • Over the years, the FDA has requested manufacturers of OTC products to submit a listing of the active and inactive ingredients in their products as a basis for helping to codify regulations governing OTC sales. • All inactive ingredients be listed on the label by quantity in descending order. • Active ingredients, as well as inactive agents, should be in no higher concentrations than necessary for the intended purpose. 153
  • 154. • The panel also recommended that the indicated objective of the active agent(s) must be on the label and that the inclusion of the name of an active agent(s) without stating the proposed benefits would be considered misleading. • Recommendations also apply to packaging and labeling guidelines to regulate advertising. • For example, the recommendations suggest that all containers for OTC therapeutic dentifrices, rinses, and gels containing fluoride have a label to identify the product, e.g., "anticaries dentifrice"; its use, e.g., "aids in the prevention of dental caries"; a warning, e.g., "Do not swallow. 154
  • 155. 155
  • 156. CONCLUSION • Dentifrices are normally used in combination with toothbrushing, providing a cosmetic (cleaning, fresh breath) and often also a therapeutic (caries, periodontal diseases, halitosis control) benefit. • Different ingredients have been included as active components in dentifrice formulations depending on the therapeutic claim. • Dentifrices represent the ideal vehicle for the application of active agents in the prevention (and therapy) of the most prevalent oral diseases, caries and periodontal diseases, since they are used in combination with toothbrushing, perhaps the most compliant behavior of modern human beings. 156
  • 157. REFERENCES • Melberg JR, Ripa LW, Leske GS. Fluoride in preventive dentisry. Theory and clinical applications. 1983, Quintessence publishers, Chicago. • Fejerskov O, Ekstrand J, Burt BA. Fluoride in dentistry. 2nd ed. 1996. Munksgaard publishers, Copenhagen. • Harris NO, Garcia-Godoy F. Primary preventive dentistry. 6th ed. 2004. Pearson prentice Hall, New Jersey . • Comprehensive Preventive Dentistry. Hardy Limeback. Wiley-Blackwell in Oxford, UK. • Axelsson P. An introduction to risk prediction and preventive dentistry. Vol 1. Quintessence publishing Co., Germany. 1999. • Stallard RE. A textbook of preventive dentistry. 2nd ed. WB Saunders, USA. 1982. • Hiremath SS. Textbook of preventive and community dentistry. 2011. 2nd ed. Elsevier publishers, New Delhi. • Maldupa I, Brinkmane A, Rendeniece I, Mihailova A. Evidence based toothpaste classification, according to certain characteristics of their chemical composition. Stomatologija. 2012;14(1):12-22. • Twetman S. Caries prevention with fluoride toothpaste in children: an update. Eur Arch Paediatr Dent. 2009 Sep;10(3):162-7. • Davies R, Scully C, Preston AJ. Dentifrices--an update. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e976-82 157
  • 158. REFERENCES • Wong MC, Clarkson J, Glenny AM, Lo EC, Marinho VC, Tsang BW, Walsh T, Worthington HV. Cochrane reviews on the benefits/risks of fluoride toothpastes. J Dent Res. 2011 May;90(5):573-9. • Demarco FF, Meireles SS, Masotti As. Over-the-counter whitening agents: a concise review. Braz Oral Res. 2009;23 Suppl 1:64- 70. • Sanz M, Serrano J, Iniesta M, Santa Cruz I, Herrera D. Antiplaque and antigingivitis toothpastes. Monogr Oral Sci. 2013;23:27- 44. • Glass RL. Fluoride dentifrices: the basis for the decline in caries prevalence. J R Soc Med. 1986;79 Suppl 14:15-7. • Ingestible Toothpaste http://ntrs.nasa.gov/archive/nasa/casi.ntrs. nasa.gov/20020091883.pdf. Accessed on 4-05-2105. • Magno MB, Nascimento GC, Da Penha NK, Pessoa OF, Loretto SC, Maia LC. Difference in effectiveness between strontium acetate and arginine-based toothpastes to relieve dentin hypersensitivity. A systematic review. Am J Dent. 2015 Feb;28(1):40-4. • Cummins D. Advances in the clinical management of dentin hypersensitivity: a review of recent evidence for the efficacy of dentifrices in providing instant and lasting relief. J Clin Dent. 2011;22(4):100-7. • Riley P, Lamont T. Triclosan/copolymer containing toothpastes for oral health. Cochrane Database Syst Rev. 2013. • S.A. Lavender, I. Petrou, R. Heu, M.A. Stranick, D. Cummins, L. Kilpatrick-Liverman, R.J. Sullivan & R.P. Santarpia. Mode of action studies of a new desensitizing dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride. Volume 23, Special Issue A, May, 2010 - p. 1A – 40A. 158
  • 159. 159

Editor's Notes

  1. N o Harris
  2. stallard
  3. gels do not include abrasives or detergents, they are easier to formulate, but their pharmacokinetics are less predictable.
  4. Before common era 400 BCE" corresponds to "400 BC". BCE stands for "Before the common era." BC means "Before Christ," or "Before the Messiah." Both measure the number of years before the approximate birthday of Yeshua/Jesus. Designation of a year in BC and BCE also have identical values.
  5. One can suppose our ancestors believed that animals that obviously had strong and continually growing teeth, such as the hare, contained some substance that would pass this attribute on to the human. Stag horns had similar characteristics. Our ancestor scientists derived this early suggestion from animal research!
  6. Mair Myrrh /ˈmɜr/ from the Hebrew '"מור"' ("mor") and Arabic مر (mur), is the aromatic resin of a number of small, thorny tree species of the genus Commiphora,[1] which is an essential oil termed an oleoresin. Myrrh resin is a natural gum. It has been used throughout history as a perfume, incense and medicine. It can also be ingested by mixing it with wine.
  7. pikenard; also called nard, nardin, and muskroot, is a class of aromatic amber-colored essential oil derived from flowering plants, the identification of which is variable. The oil has, since ancient times, been used as a perfume, as a medicine and in religious contexts, across a wide territory from India to Europe. The identity of the plants used in manufacturing of historic spikenard is not certain; Nardostachys jatamansi from Asia (the modern definition of "spikenard"), lavender from the Middle East, Alpine spikenard from Europe and possibly lemongrass have been suggested as candidates, and it is likely that different plants were used in different times and places.
  8. Protested fools They claimed It gives the teeth a fine healthy-white appearance, destroys the offensive effluvia arising from carious teeth (which is often so great as to contaminate the breath) and will not only prevent the disease of the ena mel attributed to scurvy, but even arrest its progress after it has taken place; and is really a remark that people who have suffered much from the toothache have not experienced the least relapse after the continued use of this powder. It is likewise very effective in destroying unpleasant taste in the mouth, in cleaning the tongue in cases of fever, sore throat or indigestion.
  9. mixture
  10. lukewarm
  11. Stallard
  12. One of the tests that is conducted before its approval is to determine its RDA value (radioactive dentin abrasion or relative dentin abrasivity). To determine the RDA value of toothpaste, the lab tester begins with an extracted human or cow tooth. 
  13. One of the tests that is conducted before its approval is to determine its RDA value (radioactive dentin abrasion or relative dentin abrasivity). To determine the RDA value of toothpaste, the lab tester begins with an extracted human or cow tooth. 
  14. One of the tests that is conducted before its approval is to determine its RDA value (radioactive dentin abrasion or relative dentin abrasivity). To determine the RDA value of toothpaste, the lab tester begins with an extracted human or cow tooth. 
  15. Most studies were done in North America, where water fluoridation has been common since the 1950’s.
  16. For the first time,
  17. In 1981, the formulation of Crest was changed by replacing stannous fluoride with sodium fluoride and using hydrated silica in place of calcium pyrophosphate as the abrasive system. Interestingly, these changes and the resultant increase in the amount of available and biologically active fluoride in the product resulted in the revised formulation being significantly more effective than the formulation originally approved.
  18. The caries increment for those who brushed once per day or less was higher (7.0) than those who brushed twice per day or more (5.4). From these results it may be concluded that the greatest reduction in DMFs increment occurs when brushing at least twice per day and rinsing by means of hand under the tap
  19. The collective results from the five controlled clinical studies on over 270 subjects reported in this paper, consistently demonstrate that Arm & Hammer baking soda dentifrices enhanced plaque removal effectiveness of tooth brushing to a significantly greater extent than the non-baking soda dentifrice products. J Clin Dent. 2008;19(4):111-9. Enhancement of plaque removal efficacy by tooth brushing with baking soda dentifrices: results of five clinical studies.
  20. Antiplaque, antigingivitis , antimicrobial Three studies showed a reduction in periodontal pathogens in the test group compared with the placebo group. In 1 study, the microbiological findings remained inconclusive between the 2 groups. (Am J Med Sci. 2012 may Role of dentifrices with essential oil formulations in periodontal healing) After six months, the essential oil containing dentifrice gave a 25.4% reduction (p < 0.001) in supragingival plaque accumulation and a 19.5% reduction (p < 0.001) in gingivitis compared to the placebo dentifrice. (Southeast Asian J Trop Med Public Health. 2012 Jan;43(1):243-8. Effect of an essential oil-containing dentifrice on established plaque and gingivitis. )
  21. The product, "Colgate Tartar Control Plus Whitening Fluoride Toothpaste" contains tetrasodium pyrophosphate, sodium tripolyphosphate, a copolymer, and NaF.
  22. Results - Random effect model for 3-month studies showed an effect size of -0.6 for all comparisons. The effect sizes varied from -0.3 fordentifrices with zinc chloride 0.5% to -1.1 for pyrophosphate 1.3% and copolymer 1.5% dentifrices. Meta-analysis of all the studies with 6-month follow-up gave an effect size of -1.1 (-1.5 to -0.8) and for 12-month follow-up the effect size was -13.6 (-21.4 to -5.8). CONCLUSIONS: Anticalculus dentifrices containing pyrophosphates, zinc compounds and/or co-polymers were effective in significantly reducing calculus scores (VMI). Abstract Send to: Oral Health Prev Dent. 2004;2(1):49-58. A systematic review of the effectiveness of anticalculus dentifrices. Netuveli GS1, Sheiham A.
  23. Proarginine= arginine+ calcium carbonate
  24. The development of these products is not straightforward because of interaction between formulation components and because the active ingredients must maintain their beneficial characteristics during the shelf life of the paste. Neither a therapeutic benefit (in terms of less gingivitis or less caries) nor a societal benefit (in terms of less treatment demand) has been demonstrated as a result of the anti-calculus and whitening effects of toothpastes.
  25. It not only prevents growth of both Gr (+) and Gr (–) bacteria, but also reduces the ability of fi broblast to produce infl ammatory cytokines and mediators. Copolymer strengthens the effect of triclosan Compared to chlorhexidine it is easier to combine triclosan with other toothpaste ingredients. It also does not reduce remineralizing or diminish the antibacterial quality of fl uorides [28]. The antibacterial quality of chlorhexidine is associated the prevention of glucose transport in bacteria cells
  26. Cochrane Database Syst Rev. 2013 Dec 5;12:CD010514. doi: 10.1002/14651858.CD010514.pub2. Triclosan/copolymer containing toothpastes for oral health. Riley P1, Lamont T. moderate-quality evidence showing that toothpastes containing triclosan/copolymer, in addition to fluoride, reduced plaque, gingival inflammation and gingival bleeding when compared with fluoride toothpastes without triclosan/copolymer. High-quality evidence showed that triclosan/copolymer toothpastes lead to a small reduction in coronal caries. There was weaker evidence to show that triclosan/copolymer toothpastes may have reduced root caries and calculus, but insufficient evidence to show whether or not they prevented periodontitis.
  27. In phase 1, the study is limited in scope and uses only a few subjects to determine the safe dose for humans. For dental products, this usually involves ingestion or exaggerated (three or four times per day) topical applications or both. Phase 2 involves more subjects to demonstrate the initial clinical efficacy of the drug and define a dose range for both safety and efficacy Phase 3 generally includes double-blind, controlled trials with "final" formulas to demonstrate long-term safety and efficacy. These range from 3 to 6 months for plaque and gingivitis studies to 2 or 3 years for caries studies
  28. Developing teeth of children under 6 years of age may become permanently discolored if excessive amounts of fluoride are repeatedly swallowed"; and directions for use, e.g., "Adults and children 6 years of age or older should brush teeth thoroughly at least twice daily, or as directed by a dentist or physici
  29. Actiive ingredient inactive ingredient objective warning