Clinical trial NCT00472173: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Pulp Necrosis
Keywords: Apexification
Pulp necrosis
Calcium hydroxide
MTA
pulp necrosis of an anterior immature tooth
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months
timeFrame: 30 days
Secondary outcomes:
measure: Additional criterions :- presence of clinical symptoms or not- apical morphology - depth of this apical barrier At 3, 6 and 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bretonneau
Study officials:
affiliation: Hôpital Bretonneau - Paris
name: Jean-Jacques Lasfargues, Dentist PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: URC Paris Centre
name: Raphaël SERREAU, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.