Treatments of the Necrosed Immature Teeth (REV)

Study Overview
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Brief Summary
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Estimate if the technique of revascularisation pulpaire (with some hydroxide of calcium) allows to obtain a better forecast of preservation of the tooth without complication than the conventional technique with the creation of an apicale barrier in the MTA in 24 months.

Official Title
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Randomized Comparative Test Multicentric, Forward-looking Single-blind, Between a Reference Technique and an Innovative Technic.

Conditions
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Clinical and Radiographic Success in 24 Months

Intervention / Treatment
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* Device: MTA
* Device: Hydroxide of calcium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients presenting one or monoradicular immature definitive several teeth ( open apex) with a pulpar necrosis, 6-year-old patients in 17 years the parents(relatives) of which agree to give a lit(enlightened) written consent or patients of more than 18 years old. Exclusion Criteria: general order: any pathology or treatment(processing) dissuading a treatment(processing) endodontic (patients at risk of infectious endocarditis) or pulling(entailing) an immunosuppression (diabetes, HIV, immunosuppresseurs treatments(processings) post-transplant, long-term corticoids, chemotherapies), allergy known about the used, antecedent products of cervico-facial radiotherapy, presenting subject of the communications problems, the pregnancy and the feeding. local order: generalized periodontal disease or superior located(localized) periodontal pocket in 3mm, crack or fracture(split) radiculaire, radiculaire reduction of the necrosed immature tooth

Ages Eligible for Study
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Minimum Age: 6 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional technique<br>Apical MTA barrier | Device: MTA<br>* Creation of a barrier apicale in the MTA<br>|
| Experimental: Revascularisation pulpaire<br>hydroxide of calcium | Device: Hydroxide of calcium<br>* Revascularisation pulpaire with some hydroxide of calcium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Followed in 24 months | Clinical and radiological follow-up in 24 months | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and radiographic success | Clinical and radiographic success in 3 months, 6 months, 12 months and 18 months | 3-6 months | 
| Return of the pulpaire sensibility | Test of thermal and electric sensibility | 3-6 months | 
| Obtaining of a closure apicale and of an increase of length and thickness of radiculaires walls | radiographies with an angulateur and an abutment of repositioning | 3-6 months | 
| Appearance of complications (dyschromie dental) |  | 3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrosed Immature monoradicular Teeth , Revascularisation pulpar, MTA apical barrier, Clinical and radiographic success