drugset / Trial / NCT03838068

Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

NCT03838068

Phase 2/3 Completed 33 enrolled Gihan M Abuelniel ,PhD Cairo University · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the vitality of traumatized immature anterior permanent teeth. Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Included teeth were randomly assigned to either a control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analyzed.

Timeline

Start
2017-01-18
Primary completion
2018-12-30
Completion
2019-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Biodentine Other / unclassified
Comparator Mineral Trioxide Aggregate Other / unclassified 3 mmol
Background Procaine Small molecule 0.01 mg/ml
Background Procaine Small molecule 40 mg

Indications