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

NCT ID: NCT02201498

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Deep Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Formocresol/OZE

Conventional pulpotomy technique, with formocresol and zinc oxide eugenol

Group Type ACTIVE_COMPARATOR

Pulpotomies with Formocresol/OZE and Biodentine

Intervention Type PROCEDURE

Biodentine

New technique, with biodentine

Group Type ACTIVE_COMPARATOR

Pulpotomies with Formocresol/OZE and Biodentine

Intervention Type PROCEDURE

Interventions

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Pulpotomies with Formocresol/OZE and Biodentine

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Septodont

INDUSTRY

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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BIODENT1

Identifier Type: -

Identifier Source: org_study_id

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