Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE

Not Applicable

Completed

• Conditions: Deep Dental Caries

• Registration Number: NCT02201498
• Lead Sponsor: Université de Montréal

Brief Summary

This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-28
• Study Start: 2014-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• ASA I and II
• less than 1/3 of physiologic root resorption
• asymptomatic tooth (with no history of symptoms)
• no clinical or radiological sign of pathology
• vital tooth, with carious pulpal exposure
• hemostasis must be obtained simply with pressure in less than 5 min
• teeth restored with stainless steel crowns

Exclusion Criteria

• more than 10 y.o.
• symptomatic tooth (presently or history of symptoms)
• previous pulpal treatment on the tooth
• necrotic pulp
• hyperemic pulp
• inadequate operative technique, defective restauration
• non diagnostic x-ray (pre or post treatment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical success	12 months post treatment
radiographic success	12 months post treatment

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada