Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth (APEXMTA)

November 9, 2011 updated by: Assistance Publique - Hôpitaux de Paris
Pulp necrosis is one of the main complication of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.The aim of this study is to compare the efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the reference treatment based on calcium hydroxide repeated stimulations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the study (inclusion period: 12 months). These patients will be randomly divided into two groups: one treated with MTA®, and the other one with calcium hydroxide. For each patient, the total duration of the study will be 12 months. Recalls will be performed at 15 and 21 days and then at 3, 6 and 12 months to assess by clinical and X-ray exams the main success criterion: presence of a calcified apical barrier or not. Additional criterions such as presence of clinical symptoms or not, apical morphology and depth of this apical barrier will be observed. This randomised prospective therapeutic study will allow to assess the ability of MTA® inducing apexification of a non vital immature tooth. Furthermore, it will be possible to compare for both materials the kinetics of clinical symptoms disappearance and the morphology and depth of apices.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

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

  • France
      • Paris, France, 75018
        • Hôpital Bretonneau

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

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication of apexification treatment of an anterior immature tooth
  • Patients aged 6 to 18
  • Enlightened agreement of the patient and his/her legal representatives
  • Prerequisite medical examination

Exclusion Criteria:

General disease

  • diabetes
  • immunosuppression of whatever origin (AIDS, drugs, …)
  • severe asthma
  • chronical disease requiring treatment
  • eating disorders (anorexia, bulimia, malnutrition, …) Oral disease
  • periodontal disease
  • Administration of corticoids in a period of 3 months preceding the inclusion
  • Patient with no social security cover

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Calcium hydroxide
Drug: Calcium hydroxide
Apexification treatment of the tooth with Calcium hydroxide
EXPERIMENTAL: MTA
Drug: Mineral Trioxide Aggregate
Apexification treatment of the tooth with Mineral Trioxide Aggregate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional criterions :- presence of clinical symptoms or not- apical morphology - depth of this apical barrier At 3, 6 and 12 months
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean-Jacques Lasfargues, Dentist PhD, Hôpital Bretonneau - Paris
  • Study Director: Raphaël SERREAU, MD, PhD, URC Paris Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2007

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

May 10, 2007

First Submitted That Met QC Criteria

May 10, 2007

First Posted (ESTIMATE)

May 11, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06236

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.

Clinical Trials on Dental Pulp Necrosis

Clinical Trials on Calcium hydroxide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe