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

Primary Purpose

Deep Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulpotomies with Formocresol/OZE and Biodentine
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Dental Caries

Eligibility Criteria

undefined - 10 Years (Child)All SexesAccepts 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)

Sites / Locations

  • CHU Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Formocresol/OZE

Biodentine

Arm Description

Conventional pulpotomy technique, with formocresol and zinc oxide eugenol

New technique, with biodentine

Outcomes

Primary Outcome Measures

clinical success
radiographic success

Secondary Outcome Measures

Full Information

First Posted
July 24, 2014
Last Updated
January 10, 2018
Sponsor
Université de Montréal
Collaborators
Septodont, St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02201498
Brief Title
Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Montréal
Collaborators
Septodont, St. Justine's Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Formocresol/OZE
Arm Type
Active Comparator
Arm Description
Conventional pulpotomy technique, with formocresol and zinc oxide eugenol
Arm Title
Biodentine
Arm Type
Active Comparator
Arm Description
New technique, with biodentine
Intervention Type
Procedure
Intervention Name(s)
Pulpotomies with Formocresol/OZE and Biodentine
Primary Outcome Measure Information:
Title
clinical success
Time Frame
12 months post treatment
Title
radiographic success
Time Frame
12 months post treatment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
h3t1c5
Country
Canada

12. IPD Sharing Statement

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

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