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

Deep Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201498
• Other study ID #: BIODENT1
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: January 10, 2018
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2018
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Deep Dental Caries
• Dental Caries

Intervention

Procedure:
• Pulpotomies with Formocresol/OZE and Biodentine

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Montréal	Septodont, St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical success		12 months post treatment
Primary	radiographic success		12 months post treatment