Background: Various Pulpotomy medicaments like Formocresol, Glutaraldehyde, ferric sulfate, calcium-hydroxide, MTA, Bone Morphogenic proteins, collagen, bioactive glass and laser have been advocated for use in treatment of pulpally involved primary teeth but the formocresol pulpotomy technique is the universally taught & preferred pulp therapy for primary teeth. Despite years of apparent successful use as a pulpotomy agent, formocresol has come under the attack for research & documentation in the literature which have shown it to be toxic, mutagenic & carcinogenic. This debate over the use of formocresol solution & other formaldehyde containing preparations in children’s dentistry continues. The determination of the actual effective dose and concentration for clinical application for pulpotomy in primary teeth is an important area of further research & a thorough clinical, radiographic & histologic investigation in human subjects is very much needed with various dilutions of formocresol.
Aim: To inquire about the use of formocresol for primary as well as permanent tooth pulpotomy and to know the awareness about the diluted formulations of formocresol among Indian Pediatric dentists.
Materials & Methods: The questionnaire to know the use of formocresol by the pedodontist across the India was e-mailed to 165 pediatric dentists out of whom only 120 replied/responded. Responded 38 were academicians and the remaining 82 were post graduate students.
Results: The results showed that 95% of the respondents use formocresol for routine pulpotomy procedure in primary teeth. Of those, 42% use full strength formocresol, 40% use dilute formocresol & 18% do not know what concentration they are using.
Conclusion: The study concludes that formocresol remains the most popular medicament in use for primary tooth pulpotomy followed by calcium hydroxide and MTA, gluteraldehyde and ferric sulphate in the field of Pediatric Dentistry across the country. There is a need for the diluted formocresol to be made commercially available.
No area of treatment in pediatric dentistry has been more controversial than pulp therapy. In particular the vital pulpotomy procedure and the medicaments have been the topic of debate for decades1. Various Pulpotomy medicaments like Formocresol, Glutaraldehyde, ferric sulfate, calcium-hydroxide, MTA, Bone Morphogenic proteins, collagen, bioactive glass and laser have been advocated for use in treatment of pulpally involved primary teeth. Buckley in 1904 first introduced the formocresol as a medicament since then the formocresol pulpotomy technique is considered the most universally taught & preferred pulp therapy for primary teeth2. Formocresol, though the center of much controversy, is still the most widely used medicament for primary teeth pulpotomy & an intracanal medicament which has undergone a lengthy evolution to shorten the formocresol application time & reduce the concentration of formocresol exposure to the pulp tissue3,4. The fact that only micrograms of formaldehyde is applied to pulp tissues during pulpotomy for mere minutes means pediatric pulp therapy should be considered as a “low exposure condition”5.
The first reports recommending the dilution of formocresol for use in pulpotomies came more than 42 years ago. Loos & Han in 1971 reported comparable tissue fixations with 1:5 dilutions as well with full strength in rats6. This study was followed by Morawa & others in 1975, who reported an effective result with 1:5 dilutions in a clinical study in children. Despite this long history & recommendations for the use of a diluted formula of formocresol, it does not appear to be available commercially. Hence this study was surveyed among the practicing & aspiring Pedodontists all over India about the concentration of formocresol that they use to perform pulpotomies in primary as well as in permanent teeth and, if they use dilute formocresol, where & how they obtain it.
Materials & methods
A questionnaire survey containing 10 questions inquiring the use of formocresol for routine pulpotomy procedure was mailed to 165 Pediatric Dentists all over India. Survey questions requested information about whether the practitioners used full-strength or diluted formocresol, the brand/formulation they use & if they use diluted formocresol, how the diluted form was obtained. Responses were tabulated as frequencies & analyzed.
One- hundred & twenty questionnaires were returned. “Do you use formocresol for primary tooth pulpotomy?” indicated that 95% do so. Of those who use formocresol for primary tooth pulpotomies 42.5% use full-strength, 40% diluted & 17.5% did not know the concentration that they are using (Fig. I, II).
Responses to the question “If you are using the diluted form, how do you obtain it?” indicated 47.5% prepare it themselves (Chair-side), 37.5% buy it & 15% of them responded it to be not available (Fig III). Responses to the question “what is the formulation of the diluted formocresol?” indicated 47.8% use 1:5 concentration while 42% did not know what concentration they are using!, only 7.2% & 2.9% were using 1:25 & 1:125 concentration respectively (Fig IV). It is also commonly used intracanal medicament as 59.2% of the respondents use it routinely but use of formocresol for pulpotomy in permanent teeth is by only 32.5% of the pedodontists (Fig V, VI). Formocresol was also the most preferred medicament for primary tooth pulpotomy procedures by 60.8% of the respondents; both MTA & calcium hydroxide had 12.5% preference, 7.5% glutaraldehyde & 6.7 % for ferric sulfate (Fig VII). Those who did not use formocresol commented the reason to be its hazardous effects. When questioned about any research/ clinical trials done on the use and effect of diluted formocresol, it was surprising that only 3.3% of respondents had conducted such clinical trials (Fig VIII).
King et al 7 conducted a survey on the concentration of formocresol used by pediatric dentists in Texas for primary tooth pulpotomy, according to which majority of pediatric dentists are not only still using formocresol for primary tooth pulpotomy, but they are also using full strength formocresol, either knowingly or unknowingly which indicates that there is as much confusion among practitioners about formocresol as there is variation in their technique. Similarly another survey study showed 61% of respondents used formocresol for primary tooth vital pulpotomies. 28% used undiluted and 33% used diluted. The results of this survey suggest that the majority of dentists who used formocresol were not concerned with any adverse effects8.
The responses to this survey indicate that there is much confusion among practitioners about the concentration of formocresol as there is variation in their technique. It is interesting that more than half of the respondents know & reported that they are using full strength formocresol in spite of the fact that the standard technique accepted today recommends the diluted form.
What is unknown is whether they are using full strength because they don’t know of the dilution recommendation, they know, but they are reluctant to change, or they know a diluted product is not commercially available. Also there is no standardization in the concentration of formocresol available commercially as some of the respondents who buy the diluted form of the medicament commercially but do not know what is its concentration supplied by the manufacturer. Pediatric Dentists who wish to continue to use formocresol should apply the lowest dose possible using a standardized size cotton or foam pellet for the least possible time to obtain the desired effect. When used judiciously, formocresol is a safe medicament5. Hence, it would be wise to use diluted formocresol to lower the formaldehyde exposure to the children.
Formocresol remains the most popular medicament of choice in the field of Pediatric Dentistry across the country. This is widely used & preferred in Primary teeth.
Though aware of the diluted formulation, it is less commonly used as compared to full strength formocresol. It may be because it’s appropriate procedure of preparation is not known to all.
It is time for the manufacturers of formocresol products to develop and market a dilution of this medicament to replace the “full-strength” formulation available.
Pediatric Dentists who wish to continue to use formocresol should apply the lowest dose possible for the least possible time to obtain the desired effect.
The determination of the actual effective dose and concentration for clinical application for pulpotomy in primary teeth is an important area of further research.
There is limited research with Diluted Formocresol; hence clinical human trials with least possible dilution of Buckley’s formocresol should be directed.
Acknowledgement:All the respondents who participated in this survey are acknowledged for their co-operation.
Ranly D M. Pulpotomy therapy in primary teeth: new modalities for old rationales. Pediatric Dentistry 1994; 16(6): 403-408.
Primosch RE, Glomb TA, Jerell RG. Primary tooth pulp therapy as taught in predoctoral pediatric dental programs in the United States. Pediatric Dentistry 1997; 19: 118-122.
Strange D M, Seale N S , Nunn M E , Strange M. Outcome of formocresol /ZOE sub-base Pulpotomies utilizing alternative radiographic success criteria. Pediatric Dentistry 2001; 23(3): 331-336.
Morawa A P, Straffon L H, Han S S, Corpon R E. Clinical Evaluation of Pulpotomies using Dilute Formocresol. Journal of Dentistry for Children 1975; 42: 360-363.
Milnes A R. Is Formocresol Obsolete? A Fresh Look at the Evidence Concerning Safety Issues. Pediatric Dentistry 2008; 30(3); 237-246.
Loos P J, Han SS. An enzyme histochemical study of the effect of various concentrations of formocresol on connective tissues. Oral Surg 1971; 31(4): 571-585.
King SRA, McWhorter AG, Seale NS. Concentration of formocresol used by pediatric dentists in primary tooth pulpotomy. Pediatric dentistry 2002; 24(2): 157-159.
Yoon RK, Chussid S, Davis MJ, Bruckman KC. Preferred treatment methods for primary tooth vital pulpotomies. A survey. N Y State Dent J 2008; 74(2): 47-9.
Fig 1: Use of Formocresol for routine pulp therapy procedures in primary teeth
Fig 2: Concentration of Formocresol used?
Fig 3: How is the Diluted formulation made available?
Fig 4: What is the formulation of Diluted Formocresol Used?