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

Université de Montréal

Status: Completed

Conditions: Deep Dental Caries

Treatments: Procedure: Pulpotomies with Formocresol/OZE and Biodentine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02201498

BIODENT1

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: Under 10 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Formocresol/OZE

Active Comparator group

Description:

Conventional pulpotomy technique, with formocresol and zinc oxide eugenol

Treatment:

Procedure: Pulpotomies with Formocresol/OZE and Biodentine

Biodentine

Active Comparator group

Description:

New technique, with biodentine

Treatment:

Procedure: Pulpotomies with Formocresol/OZE and Biodentine