drugset / Trial / NCT03779698

BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars

NCT03779698

Phase 4 Completed 37 enrolled King Abdulaziz University
RandomizedParallel-groupTriple-blindTreatment

Summary

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. 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.

Timeline

Start
2014-05
Primary completion
2015-12
Completion
2016-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Formocresol Other / unclassified