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

Abstract

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.

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