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| Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00472173 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Pulp Necrosis |
Drug: Hydroxide de calcium- Mineral Trioxide Aggregate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
| Official Title: | Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth |
| Estimated Enrollment: | 36 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2009 |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
General disease
Contacts and Locations| Contact: Jean-Jacques Lasfargues, dentist PhD | 0033 1 53 11 14 30 | jean-jacques.lasfargues@brt.aphp.fr |
| France | |
| Hôpital Bretonneau | Recruiting |
| Paris, France, 75018 | |
| Contact: Raphaël Serreau, MD, PhD student 0033158411180 raphael.serreau@nck.aphp.fr | |
| Principal Investigator: Jean-Jacques Lasfargues, Dentist , PhD | |
| Principal Investigator: | Jean-Jacques Lasfargues, Dentist PhD | Hôpital Bretonneau - Paris |
| Study Director: | Raphaël SERREAU, MD, PhD student | URC Paris Centre |
More Information
| Study ID Numbers: | P06236 |
| Study First Received: | May 10, 2007 |
| Last Updated: | May 10, 2007 |
| ClinicalTrials.gov Identifier: | NCT00472173 |
| Health Authority: | France: Ministry of Health |
|
Apexification Pulp necrosis Calcium hydroxide MTA pulp necrosis of an anterior immature tooth |
|
Calcium, Dietary Tooth Diseases Necrosis |
Dental Pulp Necrosis Dental Pulp Diseases Stomatognathic Diseases |
|
Pathologic Processes |
