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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
History of Changes
  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: Mineral Trioxide Aggregate
Drug: Calcium hydroxide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth

Resource links provided by NLM:

MedlinePlus related topics: Calcium Minerals
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

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 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: May 2007
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcium hydroxide Drug: Calcium hydroxide
Apexification treatment of the tooth with Calcium hydroxide
Experimental: MTA Drug: Mineral Trioxide Aggregate
Apexification treatment of the tooth with Mineral Trioxide Aggregate

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472173

Locations
France
Hôpital Bretonneau
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Jacques Lasfargues, Dentist PhD Hôpital Bretonneau - Paris
Study Director: Raphaël SERREAU, MD, PhD URC Paris Centre
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00472173     History of Changes
Other Study ID Numbers: P06236
Study First Received: May 10, 2007
Last Updated: November 9, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Apexification
Pulp necrosis
Calcium hydroxide
MTA
pulp necrosis of an anterior immature tooth

Additional relevant MeSH terms:
Dental Pulp Necrosis
Necrosis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
 Pathologic Processes
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013