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

NCT ID: NCT00472173

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-05-31

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.

Conditions

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Dental Pulp Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Calcium hydroxide

Group Type ACTIVE_COMPARATOR

Calcium hydroxide

Intervention Type DRUG

Apexification treatment of the tooth with Calcium hydroxide

MTA

Group Type EXPERIMENTAL

Mineral Trioxide Aggregate

Intervention Type DRUG

Apexification treatment of the tooth with Mineral Trioxide Aggregate

Interventions

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Mineral Trioxide Aggregate

Apexification treatment of the tooth with Mineral Trioxide Aggregate

Intervention Type DRUG

Calcium hydroxide

Apexification treatment of the tooth with Calcium hydroxide

Intervention Type DRUG

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Jacques Lasfargues, Dentist PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bretonneau - Paris

Raphaël SERREAU, MD, PhD

Role: STUDY_DIRECTOR

URC Paris Centre

Locations

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Hôpital Bretonneau

Paris, , France

Site Status

Countries

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France

References

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Beslot-Neveu A, Bonte E, Baune B, Serreau R, Aissat F, Quinquis L, Grabar S, Lasfargues JJ. Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: study protocol for a randomized controlled trial. Trials. 2011 Jul 13;12:174. doi: 10.1186/1745-6215-12-174.

Reference Type DERIVED
PMID: 21752247 (View on PubMed)

Other Identifiers

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P06236

Identifier Type: -

Identifier Source: org_study_id