Status:
COMPLETED
Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE
Lead Sponsor:
Université de Montréal
Collaborating Sponsors:
Septodont
St. Justine's Hospital
Conditions:
Deep Dental Caries
Eligibility:
All Genders
Up to 10 years
Phase:
NA
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 pu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT02201498
Start Date
September 1 2014
End Date
June 1 2016
Last Update
January 12 2018
Active Locations (1)
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1
CHU Sainte-Justine
Montreal, Quebec, Canada, h3t1c5