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

January 10, 2018 updated by: Université de Montréal

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T1C5
        • CHU Sainte-Justine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Formocresol/OZE
Conventional pulpotomy technique, with formocresol and zinc oxide eugenol
Procedure: Pulpotomies with Formocresol/OZE and Biodentine
ACTIVE_COMPARATOR: Biodentine
New technique, with biodentine
Procedure: Pulpotomies with Formocresol/OZE and Biodentine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical success
Time Frame: 12 months post treatment
12 months post treatment
radiographic success
Time Frame: 12 months post treatment
12 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Collaborators

St. Justine's Hospital
Septodont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (ESTIMATE)

July 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIODENT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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