This document provides an overview of oral hygiene products, including toothpastes, mouthwashes, and tooth bleaching agents. It discusses the composition of toothpastes and mouthwashes and reviews potential toxicities, including systemic toxicity from ingestion, local toxicity to hard and soft tissues, allergic reactions, and potential carcinogenic effects. Tooth bleaching agents like carbamide peroxide are also examined, outlining their mechanisms of action, systemic toxicity in animals, and potential for dental hypersensitivity in bleaching treatments. Safety considerations are provided around packaging, child-safe designs, and controlling fluoride levels to prevent risks like dental fluorosis.

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ORAL HYGIENE PRODUCTS
Presented by:
Dr. Hashmat Gul,
Demonstrator,
AMC, NUST,
Dental Materials.
1. INTRODUCTION

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INTRODUCTION
CLASSIFICATION OF ORAL HYGIENE PRODUCTS
Oral Hygiene Products include
Tooth pastes
Mouth washes
Tooth Bleaching Agents
Fluoride Varnishes And Gels
There is no clear Borderline Cosmetic/Dental Material.
THE AIM OF THIS CHAPTER
To review compatibility or potential side effects of oral hygiene products.
To provide adequate information to patients.
To facilitate diagnosis of side effects & assignment of symptoms to possible
causes.

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2. TOOTHPASTES &
MOUTHWASHES
COMPOSITION

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Abrasives Foaming agents Binding agents Humectants Flavourings
Silicon dioxide,
Calcium carbonate,
Aluminium
trihydrate,
Trisodium
phosphate
Sodium Lauryl Sulfate,
Cocosamidepropylbetaine
Triton-X 100,
Calcium glycero-
phosphate,
Stearyl etoxylate
Carboxymethylcellulose
Xantham gum,
Silica gel,
Cellulose gum,
Hydroxyethylcellulose
Carbopol (carbomer)
Glycerol,
Polyethylene glycol,
Propylene glycol
Saccharin,
Sorbitol,
Xylitol,
Peppermint oil,
Anise oil,
Menthol,
Eucalyptol
Antimicrobials Colorants Preservatives Anti-calculus
agents
Fluoride salts
Chlorhexidine,
Triclosan
Titanium
dioxide,
Azulene
Methyl-p-
hydroxybenzoats,
Ethanol
Tetrasodium-
pyrophosphate,
Disodium
azacycloheptane
diphosphonate
Sodium fluoride,
Sodium monofluorophosphate
Stannous fluoride,
amine fluoride
(bis-(hydroxyethyl-)-aminopropyl-N-
hydroxyethyloctadecylamine
dihydrofluoride)
COMPOSITION
2.1. SYSTEMIC TOXICITY

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ACUTE SYSTEMIC TOXICITY
Toothpastes/Mouthrinses
Normal use
No Acute Systemic
Toxicity
Ingestion by
Children
Intoxication &
poisoning
Alcohol
Alcohol induced
hypoglycaemia
Irreparable
damage to the
liver and brain
Death in severe
intoxication
Fluorides
No fatality due
to controlled
Package size
ALCOHOL TOXICITY
INCIDENCE 168 exposures per 100,000 children under 6 years of age.
SAFETY PRECAUTIONS
The American Dental Association
Child-safe bottle tops.
Warning (mouthwashes >5% alcohol).
The American Academy of Pediatrics Recommended to the U.S. Food And Drug Administration
That over-the-counter (OTC) products should
Limited alcohol content of 5% v/v to the most.
Child-safe bottle tops.

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FLUORIDES TOXICITY
The Probable Toxic Dose (PTD) of fluoride, 5 mg F/kg of body weight.
In Europe, the Maximum Permitted Concentration of Fluoride in toothpaste for
OTC sales 0.15%
Pharmacies 1.3%
SAFETY PRECAUTIONS
Package size & especially, fluoride contents be controlled.
Supervised toothpaste use by preschool children
Manufacturers should be encouraged to include this advice in labels.
CHRONIC SYSTEMIC TOXICITY
Dental Fluorosis

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FLUORIDES IN TOOTHPASTES
ChronicSystemicToxicity
Dental Fluorosis
“Low fluoride” toothpastes for small children with fluoride concentrations
from 0.025% to 0.05%.
Elevated levels of fluoride concentrations in plasma and urine after
toothpaste use observed.
Osteofluorosis
Not likely to occur with normal use of toothpaste/mouthwash
With 8 ppm fluoride in drinking water, only older subjects revealed
increased density in their bone structure with no symptoms of illness
Table. Calculated fluoride intake according to age in children using a 1,000-ppm fluoride
toothpaste compared with calculated median fluoride dose for children with fluorosis
prevalence of 28% who were given fluoride tablets

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“EPIDEMIOLOGICAL EVIDENCE”
Use of fluoride toothpaste (mean fluoride concentration 1,000 ppm)
in preschool children may be a risk factor for fluorosis.
Goa Study
• Toothpaste was the only source of fluoride apart from drinking water containing
< 0.1 ppm fluoride
• The severity of lesions > who began brushing before the age of 2 years.
• Fluoridated toothpaste is a risk factor for dental fluorosis (12.9% prevalence)
Study 2
• In areas with 1.0 mg fluoride per liter of drinking water,
• a prevalence of dental fluorosis of 60% is to be expected if drinking water is
the sole source of fluoride exposure.
FLUORIDE IN MOUTHRINSES
An extensive study of
mouth rinsing capabilities
of 474 preschool children
(ages 3–5 years)
• All subjects swallowed a significant portion of a
mouthwash.
• If a 0.1% fluoride rinse had been used, Average
ingested fluoride,1.2–2.02 mg.
• Fluoridated mouthwashes should not be prescribed for
children under 7 years of age.

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2.2. LOCAL TOXICITY AND
BIOCOMPATIBILITY
Damage to the
hard tissues
• Mechanical abrasion, which is most pronounced in
dentine.
• Chemical erosion, which is most severe in the
enamel.
Soft tissue
reactions
• May occur immediately or
• after prolonged exposure

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MECHANICAL ABRASION
ABRASIVES: Essential component of toothpastes
mechanical removal of stained tooth pellicle.
Requirements of in vitro study
Use a relevant substrate (natural teeth, dentine)
Knowledge of the abrasive compound + Abrasive particle size &
other constituents of the toothpaste.
The method of brushing( e.g. horizontal brushing)
The abrasivity of all commercially available toothpastes is generally low
No Clinical Significance.
HARD TISSUE EROSION
Erosion of enamel is seen after frequent exposure to acidic
solutions (pH 4.0 or less)
All international standards require that the pH of
Toothpastes be within the range 4.5–10.0.
Mouthrinses should not be < 4.0.

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SOFT TISSUE REACTION
Acute Reactions Of The Oral Soft Tissues To Oral Hygiene Products
Epithelial Peeling,
Mucosal Ulceration & Inflammation,
Gingivitis,
Petechiae.
Patients may complain of
A Burning Or Stinging Sensation,
Soreness Or Pain,
Staining Of The Teeth And Tongue,
Taste disturbances.
SOFT TISSUE REACTION
CAUSES Detergents & Flavoring Oils
A direct chemical injury or irritation of the soft tissues,
Allergic reactions
Soft Tissue Reaction may be affected by
The length of time the product is used,
The frequency of application,
The Concentrations of the components responsible for
the reactions observed.

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DETERGENTS
Detergents are used because they cause toothpastes to foam when applied (which is a
consumer preference), but they are also useful emulsifiers.
Sodium Lauryl Sulfate (SLS) Stearylethoxylate Cocoamidopropyl betaine
(CAPB)
Also called sodium dodecyl sulfate.
Most commonly used detergent.
For children toothpastes,
0.5% SLS to reduce
“burning”sensation.
Toxic effects
Denatures Proteins
7.5% SLS produce inflammation of
OM.
Reduction in keratinization of oral
epithelium.
Epitheliolysis of Oral mucosa.
Less toxic than SLS in cell cultures of
Human oral mucosa
For children toothpastes,
Omitted SLS &
instead have incorporated a
zwitterionic detergent,
cocoamidopropyl betaine (CAPB).
• (0.5%, 1.0%, and 1.5%)
• 42 Desquamative Reactions.SLS
• (0.64%,1.27%, and 19%)
• 3 Desquamative Reactions.CAPB
• No Oral Desquamations
No Detergent
STUDY 1: Detergents & Oral Mucosa Irritation In A Double-blind
Crossover Trial With Toothpastes
The pastes were applied for 2 min twice daily in cap splints for 4 days.

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• Painful Aphtous Ulcerations.
SLS
• Significantly Fewer Aphtous Ulcerations.
CAPB
• Significantly Fewer Aphtous Ulcerations
With Placebo (Detergent-free)No Detergent
• Amelioration Of Aphthous Ulcerations.
Stearylethoxylate
STUDY 2: Detergent effect on Recurrent aphthous stomatitis
ALCOHOL
EFFECT 0N ORAL MUCOSA
Alcohol concentrations of more than 7.5% can result in oral pain sensation, which may be
exaggerated by other ingredients of a mouthwash.
Mouthwash containing 26% alcohol Hyperkeratosis Of The Oral Mucosa.
Increased Alcohol concentrations
> Intensity of Oral Pain.
> Time required for Cessation of Post-rinsing pain.

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LOCAL REACTIONS TO ANTIMICROBIAL AGENTS
Chlorhexidine Mouthwash
Brown discoloration of the teeth and tongue and with altered taste sensation.
Superficial desquamation of the oral mucosa.
Benzethonium chloride (0.2%)
Study 1: Caused desquamative lesions of the oral mucosa in 4 out of 5 subjects
Study 2: Discoloration of the tongue and around some of the teeth in 8 out of 12
subjects.
Cetylpyridium chloride rinse burning sensation.
2.3. ALLERGIES

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• 30 allergins identified in toothpastes sold.
• The prevalence of allergic reactions to oral hygiene products is apparently low. e.g. 2% in toothpastes.
• Patients with allergic diseases such as asthma, hay fever, or allergic skin are particularly susceptible.
These patients should be informed about potential allergens in mouthwashes and toothpastes.
IgE-Mediated (Type I) Allergic Reaction Delayed Allergic Reactions (Type IV)
Urticaria,
Edema,
Erythema,
Occasionally, Vesicle Formation In The
Oral Mucosa.
May occur as late as 24–48 h after
contact with the allergen,
May be seen as
Erythema,
Ulceration,
Epithelial peeling
Types Of Allergy Associated with OHP
ALLERGY TESTING
Testing for allergic reactions can give
False negative reactions due to too-low concentrations of the sensitizer.
False positive reactions due to the contents of detergents, abrasives, etc.
No need to test the oral mucosa directly.
Open patch test recommended on the fore arm (detergents & alcohol may cause irritation under a closed patch
test , followed by attempts to define the allergin.
The services of an experienced dermatologist required.
Atopic patients comprises about 10% of the population, are characterized by the following:
Immediate vascular exudative reaction of the skin to specific exciting agents
A tendency to acquire forms of familial idiosyncrasy such as hay fever
The presence of increased levels of IgE

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ALLERGENS Allergens in OHP Allergic Reactions
Flavoring Agents
Cinnamon (cinnamic aldehyde)
Peppermint oil (Menthol)
Spearmint (L-carvone)
Anethole
CHLORHEXIDINE
Other Potential Allergens
Acetamide,
Azulene,
Benzoates,
Chloro-acetamide,
Di-chlorophene,
Formaldehyde
Contact urticaria
A Lichenoid Reaction
Allergic Contact Cheilitis
Induced Asthma
Potential Anaphylactic Responses
particularly In Japanese Patients.
Contact Dermatitis
2.4. MUTAGENICITY,
CARCINOGENICITY,
AND TERATOGENICITY.

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Toothpastes, as opposed to tooth brushing, may not be essential
for maintaining oral health.
PROBABLE HUMAN CARCINOGENS
Tetra-chloroethylene
Benzene
Chlorofom
Triclosan (Anti-microbial) resistant-strains.
Relationship of Oral Cancer & Mouthwashes
Insufficient evidence.
Regular daily use of alcohol-containing mouthwashes
could contribute to elevated risks of oral cancers among smokers
3. TOOTH BLEACHING AGENTS

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HISTORY
Removal of intrinsic staining may require chemical agents.
Various acids such as Oxalic acid and Hydrochloric acid have
been recommended previously.
For the last 50 years, bleaching of teeth with hydrogen
peroxide (30–35%) or compounds that release hydrogen
peroxide, such as carbamide peroxide and sodium perborate,
have been described as most suitable for bleaching vital and
non-vital teeth
CARBAMIDE PEROXIDE
Tooth whitener , Carbamide peroxide, a mild anti-septic (also called urea hydrogen peroxide,
perhydrit, hyperol, or perhydrol urea) is an addition complex of hydrogen peroxide with urea,
which has a mild effect on plaque and gingivitis.
On contact with saliva, carbamide peroxide dissociates to hydrogen peroxide (34%) & urea.
Haywood and Heymann introduced bleaching of teeth with 10% carbamide peroxide gels
placed in custom-built trays to be worn by patients at night for 2–6 weeks.
A number of products became available with 10–15% carbamide peroxide gels, not only for
professional use but also in kits with custom-fabricated trays for OTC sales.

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THE SYSTEMIC TOXICITY
RAT STUDIES
Whiteners with carbopol in addition to carbamide peroxide have > toxicity than
carbamide peroxide alone. (LD50 87.2 mg/kg body weight versus 143.8 mg/kg body weight).
Cherry et al. showed that 5,000 mg/kg body weight produces serious lethal symptoms.
Dahl & Becher showed that 15 mg/kg gave rise to histological changes in the gastric mucosa
that were not seen with 5 mg/kg body weight.
IN HUMANS
Dahl and Becher calculated an exposure limit for humans of 10 mg carbamide peroxide per day.
Carbamide peroxide (10%) as used in bleaching agents delivers 3.5% hydrogen peroxide.
Exposures to 3% hydrogen peroxide (common household strength) are usually benign.

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THE MECHANISMS INVOLVED IN
HYDROGEN PEROXIDE POISONING
Gastric
catabolism of
hydrogen
peroxide to
oxygen and
water
uptake by the
bloodstream
Venous
embolism
Cerebral
infarction
Stroke
Successful treatment with hyperbaric oxygen.
LOCAL TOXICITY AND TISSUE
COMPATIBILITY

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In mouthwashes, 3% hydrogen peroxide or 10% carbamide
peroxide is apparently limited.
Erosive gingival lesions are not normally expected to occur
with limited/occasional use of 3% hydrogen peroxide
mouthwashes.
Carbamide peroxide bleaching systems sold for home use
are anhydrous and extremely hypertonic and thus might be
expected to produce gingival lesions with prolonged contact.
DENTAL HYPERSENSITIVITY
to Cold stimuli was reported in an At-home tooth bleaching protocol
with 10% carbamide peroxide.
30–35% hydrogen peroxide for professional tooth bleaching reported some post-
treatment sensitivity that dissipated with time.
Greater hypersensitivity observed if enamel is etched prior to bleaching.
Vital teeth in patients with large restorations, extensive erosions/abrasions of the
cervical tooth surface, or pronounced enamel cracks should be bleached with caution
because increased risk of penetration of potential toxic substances to the pulp.
Hydrogen peroxide at concentrations of 12% in gels, dentifrices, and mouthrinses is
not carcinogenic, mutagenic, or teratogenic

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4. FLUORIDE VARNISHES & GELS
INTRODUCTION
History
Topical Fluoride application done by Professionals for more than half a century.
But it has become popular in the last 3 decades.
Topical Fluoride Applications
Fluoride aqueous solutions by Health Professionals.
Fluoride gels Use at Home in prefabricated or custom-built trays.
Fluoride varnishes by Health Professionals only.

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FLUORIDE GELS
TYPES OF FLUORIDES IN
GELS
LOCAL EFFECTS SYSTEMIC EFFECTS
Sodium fluoride,
Stannous fluoride,
Amine fluoride,
Acidulated phosphate
fluoride (APF).
Disagreeable taste & may
stain teeth.
Acidic taste (pH 3.0) & will
etch teeth & Ceramic or
Composite restorations.
For Home Use, Gels usually contain
1.1% Sodium Fluoride or about one-
half of the fluoride concentration
used in gels for professional
application.
Potential Toxic Dose (PTD) of fluoride
=5mg/kg body weight (average)
A 2-year-old child of 12.3 kg would
need to swallow only 5 ml of a
1.23% APF gel to reach the PTD.
STUDIES TO ACCESS FLOURIDE TOXICITY
Spak and colleagues
used 3 g of a low-
fluoride gel(0.42%
fluoride) for a 5-min
application in custom
trays in 10 adults.
About 40% of the
gel was swallowed
Caused gastric
injuries in 7/10
subjects, observed at
gastroscopy 2 h
after application.
Minor clinical
significance (Rapid
recovery of Gastric
mucosa & just 2-4
times application
annually)

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STUDIES TO ACCESS FLOURIDE TOXICITY
Application of gels
containing 1.23% or
0.1% fluoride in
Children & Adults.
Plasma fluoride levels
sufficient to cause a
decrease in urinary
concentration ability.
One of the adults in
this study experienced
gastrointestinal
symptoms.
FLUORIDE VARNISHES
ADVANTAGES DISADVANTAGES
The amounts used are much smaller than for
gels.
Slow Fluoride Release.
Fluoride is in suspension rather than dissolved.
Designed to adhere to the teeth.
Systemic fluoride exposure from varnishes is
expected to be lower than for gels.
The plasma fluoride levels recorded after
varnish use were lower by a factor of 10 than
those found with fluoride gels.
Fluoride concentrations in varnishes is much
greater than in gels.
Designed for use by Health Professionals only.

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VEHICLE SUBSTANCES
The substances used to form the fluoride vehicle in Gels and varnishes.
FLUORIDE SYSTEM VEHICLE SUBSTRATE SIDE EFFECT
Gels Cellulose No Toxicity
Varnishes Duraphat
Neutral Colophonium
BiFluorid
a mixture of ethyl
acetate &
isoamylpropionate
Colophony/Rosin Sensitization rxn.
Ethyl acetate Non-toxic.
Isoamylpropionate Low toxicity.