Ferric sulfate is more safe than formocresol as pulpotomy agent with almost same outcome.

1. Ferric Sulfate as a pulpotomy
medicament in primary teeth
Case presentation &
literature review
Osama H. AlKhalifa

2. Pulpotomy
A pulpotomy entails the removal of the coronal pulp
and maintenance of the radicular pulp.
There are three main approaches to this technique
i) preserving the radicular pulp in a healthy state
ii) rendering the radicular pulp inert
iii) encouraging tissue regeneration and healing at
the site of radicular pulp amputation
UK National Clinical Guidelines in Paediatric Dentistry 2006

3. Pharmacotherapeutic Pulpotomy Techniques
 Formocresol
 Ferric sulfate
 MTA
 Calcium hydroxide
 Glutaraldehyde

4. Nonpharmacotherapeutic Pulpotomy
Techniques
 Electrosurgery
 Lasers
Nd:YAG, Er:YAG, carbon-dioxide and argon laser

5. Indications
 A carious or mechanical exposure of vital coronal
pulp tissue
 Asymptomatic tooth or only transient pain
Pulp therapy for primary molars
UK National Clinical Guidelines in Paediatric Dentistry 2006

6. Indications
The pulpotomy procedure is indicated when caries
removal results in pulp exposure in a primary tooth
with a normal pulp or reversible pulpitis or after a
traumatic pulp exposure
Guideline on Pulp Therapy for Primary and Young Permanent Teeth
American Academy of Pediatric Dentistry 2004

7. Pulp therapy for primary molars
UK National Clinical Guidelines in Paediatric Dentistry 2006
Procedure
• Local anaesthetic
• Good isolation with rubber dam
• Removal of caries

8. Pulp therapy for primary molars
UK National Clinical Guidelines in Paediatric Dentistry 2006
• Complete removal of roof
of pulp chamber
preferably with a non-end
cutting bur
• Removal of coronal pulpal
tissue with sharp sterile
excavator or large round
bur in a slow handpiece

9. Pulp therapy for primary molars
UK National Clinical Guidelines in Paediatric Dentistry 2006
• Attain initial radicular pulpal haemostasis by
gentle application of sterile cotton pledget
moistened with saline (haemostasis should
be achieved within four minutes)

10. Pulp therapy for primary molars
UK National Clinical Guidelines in Paediatric Dentistry 2006
• Selection of medicament for direct
application to radicular pulp stumps:
1) 15.5% ferric sulphate solution
(Astringedent, Ultradent Products Inc. USA)
burnished on pulp stumps with microbrush
for 15 seconds to achieve haemostasis,
followed by thorough rinsing and drying

11. Pulp therapy for primary molars
UK National Clinical Guidelines in Paediatric Dentistry 2006
2) 20% (1:5 dilution) Buckley’s formocresol solution
applied to radicular pulp on a cotton pledget for five
minutes to achieve superficial tissue fixation
3) MTA paste applied over radicular pulp with
proprietary carrier
4) Well-condensed layer of pure calcium hydroxide
powder applied directly over radicular pulp

12. Pulp therapy for primary molars
UK National Clinical Guidelines in Paediatric Dentistry 2006
 Application of a lining (if
appropriate) such as
reinforced glass ionomer or
zinc oxide eugenol cement
 Definitive restoration to
achieve optimum external
coronal seal (ideally an
adhesive restoration of
preformed metal crown)

13. Guideline on Pulp Therapy for Primary and Young Permanent Teeth
American Academy of Pediatric Dentistry 2004
The coronal pulp is amputated, and the
remaining vital radicular pulp tissue surface
should be treated with a medicament such as
formocresol or ferric sulfate or with
electrosurgery to preserve the radicular
pulp’s health. The coronal pulp chamber is
filled with a suitable base, and the tooth is
restored with a restoration that seals the
tooth from microleakage

14. Signs of Failure
 Clinical
Spontaneous pain,
tenderness to percussion,
swelling, sinus and
pathological mobility
 Radiographic
Internal or external root
resorption and periapical or
inter-radicular radiolucency

15. Clinical Case
A female patient aged 9 years presented with
transient pain on temporarily filled lower left
primary 2nd molar .Examination revealed presence
of deep caries on the mesial surface and below the
temporary filling. Pulpotomy was done using ferric
sulfate technique (Astringedent, Ultradent Products
Inc. USA). Then ZnoE base and amalgam
restoration were placed

16. Clinical Case
Before After
Deep
caries

17. Clinical Case
After 6 months After12 months

18. Formocresol
 Full-strength FC (Buckley’s Formocresol)
19% formaldehyde and 35% tricresol in a
water and glycerin solution
 Formocresol is often called a “fixative” agent
due to its preservative action on the coronal
layers of the radicular pulp stumps

19. Formocresol
Concerns
1- Carcinogenicity
2- Mutagenicity
3- immune sensitization.

20. Formocresol
Formocresol…….
safe………
or……
not?

21. Do We Still Need Formocresol in Pediatric
Dentistry?
Casas et al, J Can Dent Assoc 2005
Pashley 1980 found that Up to 10% of the
formaldehyde from a formocresol pulpotomy
was absorbed systemically in dogs

22. Do We Still Need Formocresol in Pediatric Dentistry?
Casas et al J Can Dent Assoc 2005
Ranly 1985 found that radioactively labelled
formaldehyde was distributed throughout the
viscera of rats following formocresol
pulpotomy in a single molar

23. Do We Still Need Formocresol in Pediatric
Dentistry?
Casas et al J Can Dent Assoc 2005
Swenberg 1980, and Kerns,1983 found a
relationship between exposure to
formaldehyde and the development of
squamous cell carcinoma in rats

24. Do We Still Need Formocresol in Pediatric
Dentistry?
Casas et al J Can Dent Assoc 2005
Bolt 1987 reported evidence of an interaction
between formaldehyde and DNA in rats that
produced experimental tumours

25. Do We Still Need Formocresol in Pediatric
Dentistry?
Casas et al J Can Dent Assoc 2005
Block 1978 detected antibody formation
leading to immune sensitization to
formaldehyde after formocresol pulpotomy in
dogs

26. Do We Still Need Formocresol in Pediatric
Dentistry?
Casas et al J Can Dent Assoc 2005
The International Agency for Research on Cancer
(IARC) of the World Health Organization recently
reclassified formaldehyde as a known human
carcinogen. In a June 2004 press release, the IARC
stated that there was sufficient evidence that
formaldehyde causes nasopharyngeal cancer,
limited evidence that it causes nasal and paranasal
sinus carcinoma and strong but not sufficient
evidence that formaldehyde causes leukemia in
human

27. Do We Still Need Formocresol in Pediatric
Dentistry?
Casas et al J Can Dent Assoc 2005
With the known risks of formocresol and
proven alternatives with equal efficacy,
formocresol use in pediatric dentistry is
unwarranted.

28. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
The suggestion that formocresol use in
pediatric dentistry is unwarranted because of
safety concerns has been promoted
(unsuccessfully in North America) for several
decades

29. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
An adult takes in 10.55 mg of formaldehyde
per day
• 9.4 mg/day from food,
• 1 mg/day from inhalation
• 0.15 mg/day from water

30. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
The estimated dose of formaldehyde
associated with one pulpotomy procedure is
0.1 to 0.5 mg (author’s calculation)

31. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
Humans are well equipped physiologically to
handle this exposure through multiple
pathways for conversion of formaldehyde and
its oxidation product formate

32. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
Inhaled formaldehyde appears to be readily
absorbed by the upper respiratory tract but is
not distributed throughout the body because
it is so rapidly metabolized.

33. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
Rolling and Thulin 1976 found no increase in
either immune response or allergic reactions
in 128 children who had undergone
formocresol pulpotomy

34. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
Doi and others 2003 found that the
prevalence of IgE sensitization to
formaldehyde was very low among Japanese
children

35. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
Ribeiro 2004 assessed the mutagenic
potential of formocresol. Using a mouse
lymphoma cell line and cultured human
fibroblasts and a series of dilutions of
formocresol similar to clinical doses, Ribeiro
found that formocresol did not produce
detectable DNA damage and should not be
considered genotoxic.

36. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
Swenberg 1980 and and Kerns 1983 showed that nasal
squamous cell carcinoma developed in rats exposed to
formaldehyde gas at concentrations of 6 ppm and higher for
6 hours/day,5 days per week for 24 months.
However, the formaldehyde concentrations that resulted in
cancer were more than1,000 times typical human
environmental exposures and 8 times the U.S. occupational
exposure limit (0.75 ppm) and are therefore not
representative of human experience .Moreover, the
experimental conditions that resulted in nasal cancers in
rodents in no way resemble the conditions associated with a
5-minute exposure to microgram quantities of formaldehyde,
as experienced by a child undergoing formocresol
pulpotomy.

37. Persuasive Evidence that Formocresol
Use in Pediatric Dentistry Is Safe
Milnes, J. Can Dent Assoc 2006
The IARC reclassification was based primarily on
the results of a single National Cancer Institute
(NCI) study among workers in formaldehyde
industries. That study included many workers at
several plants, but only a small number of people
working at a single plant were found to have a rare
form of cancer. Clearly, confounding variables may
have affected the results. Recognizing these
uncertainties, the NCI has agreed to update the
study. That research is now in progress

38. Ferric Sulphate
Ferric sulphate promotes pulpal haemostasis
through a chemical reaction with blood. It has
been proposed as a pulpotomy agent on the
basis that it controls pulpal bleeding and
forms a protective metal-protein clot over the
underlying vital radicular pulp

39. Ferric Sulphate
Clinical outcome
A systematic review of pulp therapy for primary
molars identified three randomised controlled
clinical trials where the follow up period had been at
least 12 months. From the findings of these studies,
it was concluded that the formocresol pulpotomy,
the ferric sulphate pulpotomy, electrocautery or
pulpectomy were equally successful techniques
Nadin et al., cochrane library review 2003

40. Ferric Sulphate
Clinical outcome
A meta-analysis of formocresol versus ferric
sulphate primary molar pulpotomies included
94 studies found both approaches to have a
similar rate of clinical and radiographic
success
[Loh et al. Pediatric Dentistry 2004]

41. Ferric Sulphate
Clinical outcome
A meta-analysis included 11 studies showed
that pulpotomies performed with either
formocresol or ferric sulphate have similar
clinical and radiographic success.
Peng et al., Int Endod J. 2007

42. Effectiveness of 4 Pulpotomy Techniques
Randomized Controlled Trial
Huth et al, J Dent Res, 2005
Technique Clinical success
rate
Radiographic
success rate
diluted formocresol 96% 85%
ferric sulfate 100% 86%
Er:YAG laser 93% 78%
calcium hydroxide 87% 53%

43. Advantages of ferric sulphate over
formocresol
1- Safety
2- Ease and speed of use
3- less pungent

44. Discussion
What would you prefer…..
formocresol….
or
ferric sulfate?
Thank you