ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Efficacy of Guteraldehyde As Pulpotomy Agent in Primary Molars
Clinical Question In cariously exposed primary molars, is gluteraldehyde as effective as formocresol as pulpotomy agent?
Clinical Bottom Line As a pulpotomy agent for primary molars, glutaraldehyde has shown to be effective based on two clinical trials without control groups using different glutaraldehyde preparations and one controlled clinical trial with small sample size and short observation time. Replacing formocresol using glutaraldehyde as primary tooth pulpotomy agent is not substantiated due to lack of high level evidence.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 2517845Prakash/198930 patients were treated with formocresol, 30 were treated with gluteraldehyde Comparative Study
Key resultsTreated teeth were examined after 1, 3 and 6 month. Only 22 patients in FC group and 20 patients in gluteraldehyde group available for entire 6 month follow up. In the glutaraldehyde group 100% clinical and radiological success rate was observed while In the formocresol group 90% clinical and radiological success rate was seen over a six-month period.
#2) 8378049Tsai/1993Started with 201 children aged 4 to 7 years- 258 primary molars in total. After 36 months, 150 teeth were available with complete clinical records and radiographs Comparative Study
Key resultsThe subjects were divided into four groups with four different preparations of gluteraldehyde (2% buffered, 2% unbuffered, 5% buffered, and 5% unbuffered) The average radiographic success rate was only 78.7%. The group treated with 5% buffered glutaraldehyde had the highest success rate (87.5%); the overall clinical success was 98%, while the lowest success was with the 5% unbuffered solution the (74.1%), although no significant difference was found among the four groups. For post-operative follow up, clinical evaluation was performed and periapical radiographs taken every 6 months or 1 year.
#3) 2120303Fuks AB / 199053 primary molars of 32 2nd grade children (average 7 yo)Case series
Key resultsAfter performing pulpotomies using a formulation of 2% buffered gluteraldehyde, teeth were examined clinically and radiographically at 6, 12 and 25 month recalls. The failure rate increased from 5.7% at the 6 month recall to 18% at the 25 month recall.
#4) 2517845Garcia-Godoy / 198649 children aged 4-9 years old w/ 49 cariously exposed primary molars (originally 55 patients, 6 moved out of the country before 42 months had been reached)Case series
Key results49 teeth were available for clinical and radiographical exam at 42-month follow up. All pulpotomies were done using 2% unbuffered glutaraldehyde. The treatment was clinically and radiographically successful for 98% of the teeth- only 1 tooth was found radiographically to be a failure (furcation radiolucency) at 22 months.
Evidence Search (("Formocresol" [Supplementary Concept]) AND "Glutaral"[Mesh]) AND "Pulpotomy"[Mesh]
Comments on
The Evidence
While there is evidence of the efficacy of gluteraldehyde as a pulpotomy agent, more randomized controlled trials comparing gluteraldehyde against formocresol must be performed. There is only one clinical trial directly comparing gluteraldehyde pulpotomy and formocresol pulpotomy (Prakash), however, this study has small sample size and only 6 month follow up period. Most studies on gluteraldehyde pulpotmies have no control groups. An optimal Gluteraldehyde preparations and application methods also need to be identified as there are different formulations of gluteraldehyde used in different studies. Randomized controlled clinical trials with long-term follow up are needed to declare gluteraldehyde a pulpotomy agent with the effectiveness of formocresol.
Applicability Formocresol, widely used as pulpotomy agent of choice in the United States, has known toxicity and a possibility of mutagenesis. As the rate of children who need dental care in the United States continues to increase, it is imperative to seek out pulpotomy agents without toxicity and with similar efficacy rates. Gluteraldehyde, which is less toxic with minimal surrounding tissue penetration, has been considered to be a promising substitute for formocresol, although some studies have shown a higher failure rate with long-term follow up.
Specialty/Discipline (General Dentistry) (Pediatric Dentistry)
Keywords Pulpotomy, Pulpotomies, gluteraldehyde, formocresol
ID# 2450
Date of submission: 03/01/2013spacer
E-mail coppolak@livemail.uthscsa.edu
Author Kevin Coppola
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Zheng Xu, DDS
Faculty mentor/Co-author e-mail xuz@uthscsa.edu
Basic Science Rationale
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