Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE
Not Applicable
Completed
- Conditions
- Deep Dental Caries
- Interventions
- Procedure: Pulpotomies with Formocresol/OZE and Biodentine
- 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
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
- Arm && Interventions
Group Intervention Description Biodentine Pulpotomies with Formocresol/OZE and Biodentine New technique, with biodentine Formocresol/OZE Pulpotomies with Formocresol/OZE and Biodentine Conventional pulpotomy technique, with formocresol and zinc oxide eugenol
- Primary Outcome Measures
Name Time Method clinical success 12 months post treatment radiographic success 12 months post treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada