At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars: A 12-Month Randomized Controlled Clinical Trial
In Brief
A Phase 4 clinical trial evaluating BiodentineTM and Formocresol for Dental Caries and Pulpotomy. Completed, enrolled 37 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
In the experimental group, BiodentineTM was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.
In control group, a sterile cotton pellet moistened with 1:5 concentration formocresol then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.