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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Pulp Necrosis

Intervention / Treatment
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* Drug: Mineral Trioxide Aggregate
* Drug: Calcium hydroxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium hydroxide<br> | Drug: Calcium hydroxide<br>* Apexification treatment of the tooth with Calcium hydroxide<br>|
| Experimental: MTA<br> | Drug: Mineral Trioxide Aggregate<br>* Apexification treatment of the tooth with Mineral Trioxide Aggregate<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apexification, Pulp necrosis, Calcium hydroxide, MTA, pulp necrosis of an anterior immature tooth