NCT02201498CompletedNot Applicable
A New Technique for Primary Molar Pulpotomy : A Randomized Clinical Trial Comparing the Radiographic and Clinical Success of the Formocresol-zinc Oxide Eugenol Technique and the Biodentine Technique
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Université de Montréal
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- clinical success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Formocresol/OZE
Active Comparator
Conventional pulpotomy technique, with formocresol and zinc oxide eugenol
Intervention: Pulpotomies with Formocresol/OZE and Biodentine (Procedure)
Biodentine
Active Comparator
New technique, with biodentine
Intervention: Pulpotomies with Formocresol/OZE and Biodentine (Procedure)
Outcomes
Primary Outcomes
clinical success
Time Frame: 12 months post treatment
radiographic success
Time Frame: 12 months post treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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