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

Phase 3

Completed

• Conditions: Dental Pulp Necrosis
• Interventions: Drug: Calcium hydroxide; Drug: Mineral Trioxide Aggregate

• Registration Number: NCT00472173
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-11
• Primary Completion: 2010-11
• Study Completion: 2011-05
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-09
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium hydroxide	Calcium hydroxide	-
MTA	Mineral Trioxide Aggregate	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Bretonneau; 🇫🇷 Paris, France