Background: The objective of this clinical study was to prospectively compare the clinical and radiographic success rates of BiodentineTM 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 BiodentineTM 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 BiodentineTM and formocresol groups were 100%, while the radiographic success rates for BiodentineTM 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 BiodentineTM and formocresol groups, respectively.
Conclusions: Both BiodentineTM 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.
Keywords: BiodentineTM; Formocresol; Primary molars; Pulpotomy; Randomized clinical trial.