Pulpotomy has long been accepted as the treatment of choice for cariously-exposed primary teeth. Formocresol (FC), glutaraldehyde (GA), ferric sulfate (FS), calcium hydroxide (CH), electrosurgery (ES), laser, and mineral trioxide aggregate (MTA) are among the frequently-used pulpotomy medicaments. Although FC has been the gold standard for pulpotomies for over 80 years, following reports on the carcinogenicity of formaldehyde, 1 its use has been abandoned in several countries over the past decade. This stimulated extensive research to find an alternative medicament or technique that can achieve similar or greater success rates. GA, CH, FS, ES, laser, and MTA have all been evaluated through numerous clinical trials. 2-7 These data have been the basis for narrative 8,9 and systematic reviews. 10-12 While the true value of evidence-based systematic reviews and randomized clinical trials cannot be underestimated, they are limited by the quality of the studies included in those reviews.In 2006, Fuks and Papagiannoulis analyzed the quality of data from published clinical trials using a specifically modified version of standardized criteria. 13,14 They proposed a clear criterion-based grading system that was expected of a high-quality clinical trial designed to evaluate pulpotomies in primary teeth. A recent review applied the above criteria to evaluate the quality of evidence available to support the long-term efficacy of MTA for pulpotomies in primary teeth, and reported that there was no evidence that MTA
AbstractThe aim of the present study was to perform a qualitative assessment of published clinical studies, using the Medline database between 2006 and 2016, on commonly used pulpotomy medicaments. Standardized criteria proposed by Fuks and Papagiannoulis in 2006 was used by three independent examiners who assessed a total of 64 studies and graded the papers as grades A (38-42), B1 (32-37), B2 (25-31), or C (<25) based on the score obtained. Dropout rates were calculated based on the initial sample and the final sample used for analysis. Only three papers were grade A, two of which were parts of the same clinical study with results presented at 24 and 42 months, respectively. Twelve papers were graded B1, 19 were graded B2, and 30 were graded C. The quality of evidence seemed greatest for formocresol (2 grade A, 21 grade B), followed by electro surgery (1 grade A study), calcium hydroxide (11 grade B studies), and ferric sulfate (11 grade B studies). The current qualitative assessment clearly highlights the inadequacies in the published studies, especially the study design and clinical and radiographic criteria, thus provides a basis for formulating specific guidelines for researchers embarking on conducting clinical trials on pulpotomy medicaments.