Biodentine(TM) versus formocresol pulpotomy technique in primary molars: a 12–month randomized controlled clinical trial

BACKGROUND: The objective of this clinical study was to prospectively compare the clinical and radiographic success rates of Biodentine(TM) pulpotomies versus formocresol pulpotomies in children vital primary molars. METHODS: A randomized, split–mouth study design was used with a sample of 37 healthy children aged 4– to 8–year–old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the Biodentine(TM) pulpotomy group or the formocresol pulpotomy group. Children were followed–up at 3, 6 and 12 months for clinical evaluation and at 6 and 12 months for radiographic evaluation. Data were collected, tabulated and analyzed using Fisher exact and McNemar tests. The level of significance was set at P < 0.05. RESULTS: At 12 months, the clinical success rates of both Biodentine(TM) and formocresol groups were 100%, while the radiographic success rates for Biodentine(TM) and formocresol groups were 100% and 98.1%, respectively. There was no statistically significant difference between both groups (P=1). The only observed radiographic failure was furcal radiolucency in the formocresol group at 12–month interval. Pulp canal obliteration was radiographically observed in 10/56 (17.9%) and 7/56 (12.5%) cases in the Biodentine(TM) and formocresol groups, respectively. CONCLUSIONS: Both Biodentine(TM) and formocresol pulpotomy techniques demonstrated favorable clinical and radiographic outcomes over a 12-month period without any significant difference. TRIAL REGISTRATION: Registered on NCT03779698. Date of Registration: 18 December 2018.