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

Dental Pulp Necrosis Clinical Trial

— APEXMTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472173
• Other study ID #: P06236
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2007
• Last updated: November 9, 2011
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis

Intervention

Drug:
• Mineral Trioxide Aggregate
Apexification treatment of the tooth with Mineral Trioxide Aggregate
• Calcium hydroxide
Apexification treatment of the tooth with Calcium hydroxide

Locations

Country	Name	City	State
France	Hôpital Bretonneau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months		30 days	No
Secondary	Additional criterions :- presence of clinical symptoms or not- apical morphology - depth of this apical barrier At 3, 6 and 12 months		12 months	No