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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00472173
First received: May 10, 2007
Last updated: November 9, 2011
Last verified: November 2011

May 10, 2007
November 9, 2011
May 2007
November 2010   (final data collection date for primary outcome measure)
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00472173 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth
Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dental Pulp Necrosis
  • Drug: Mineral Trioxide Aggregate
    Apexification treatment of the tooth with Mineral Trioxide Aggregate
  • Drug: Calcium hydroxide
    Apexification treatment of the tooth with Calcium hydroxide
  • Active Comparator: Calcium hydroxide
    Intervention: Drug: Calcium hydroxide
  • Experimental: MTA
    Intervention: Drug: Mineral Trioxide Aggregate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
May 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00472173
P06236
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Jean-Jacques Lasfargues, Dentist PhD Hôpital Bretonneau - Paris
Study Director: Raphaël SERREAU, MD, PhD URC Paris Centre
Assistance Publique - Hôpitaux de Paris
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP