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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date † | May 10, 2007 | ||||||||
| Last Updated Date | May 10, 2007 | ||||||||
| Start Date † | May 2007 | ||||||||
| Current Primary Outcome Measures † |
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months [ Time Frame: 30 days ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures † |
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 ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth | ||||||||
| Official Title † | Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study | ||||||||
| Condition † | Dental Pulp Necrosis | ||||||||
| Intervention † | Drug: Hydroxide de calcium- Mineral Trioxide Aggregate | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 36 | ||||||||
| Estimated Completion Date | May 2009 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: General disease
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| Gender | Both | ||||||||
| Ages | 6 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | France | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00472173 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Assistance Publique - Hôpitaux de Paris | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||||||
| Verification Date | May 2007 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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