Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste

Study Overview
=================
Brief Summary
-----------------
The maintenance of primary teeth until their exfoliation has been one of the main purposes of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to conduct a randomized clinical trial is to evaluate the performance of endodontic treatment in primary teeth using MTA paste, comparing to Vitapex.

Detailed Description
-----------------
After approval by the ethics committee of the patients Faculty of Dentistry, University of São Paulo that having root canal filling of primary teeth will be invited to participate in the study. A clinical examination and prior radiographic diagnosis will be-held. The patient will be randomized to one of two groups and will be made the endodontics by a dentist. The patient will be accompanied with periods of one week, one month and three months by a blinded evaluator. The outcome will be the success or failure of endodontic treatments evaluated through permanent tooth in the arch on clinical and radiographic conditions of normality. The longevity of the treatments will be evaluated by estimating survival rates by Kaplan-Meier. The differences between the survival rates according to the type of proposed endodontic treatment will be analyzed using the log-rank test with a minimum significance level of 5%.

Official Title
-----------------
Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste - Protocol of a Phase 2 Randomized Clinical Trial

Conditions
-----------------
Teeth, Endodontically-Treated

Intervention / Treatment
-----------------
* Drug: Endodontic treatment using Vitapex
* Drug: Endodontic treatment using MTA paste


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary teeth with pulp diagnosis and need endodontic treatment Patients whose guardians consent to their participation in the survey fistula or abscess bone rarefaction or visual diagnosis teeth in the remaining tooth structure and location of the injury rehabilitation permit do not have internal or external resorption involving more than one third of the root length have no bone loss in lateral root and disruption crypt and the presence of at least half of root Exclusion Criteria: health problems systemic congenital facial deformities facial tumors syndromes

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitapex<br>Endodontic treatment using Vitapex | Drug: Endodontic treatment using Vitapex<br>* Endodontic treatment using Vitapex<br>|
| Experimental: MTA paste<br>Endodontic treatment using MTA paste | Drug: Endodontic treatment using MTA paste<br>* Endodontic treatment using MTA paste<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success or failure of endodontic treatments | The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality, able to maintain or restore the health of periodical tissues after the treatment. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions will be between the initial and follow-up radiographs. Radiographs will be scanned and the end of the bone rarefactions starting area and will be measured on a software image analysis. | 3 months |