Endodontic Treatment of Necrotic Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial

Study Overview
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Brief Summary
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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 with longitudinal follow-up of two years, double blind, to compare the degree of success of endodontic treatment in primary among the most used folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.

Detailed Description
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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 and also a quality of life questionnaire regarding oral health (- ECOHIS Early Childhood Oral Health Impact Scale) will be-held. The patient will be randomized to one of two groups and will be held endodontics by a blind handler. The patient will be accompanied with periods of one week, six months, 12 months and 24 months by a blinded evaluator. At the last visit of the review ECOHIS questionnaire will be reapplied to those responsible. 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
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Endodontic Treatment of Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial

Conditions
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Endodontic Treatment of Primary Teeth

Intervention / Treatment
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* Drug: Endodontic treatment using Vitapex
* Drug: Endodontic treatment using Guedes Pinto


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


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: Guedes Pinto Paste<br>Endodontic treatment using Guedes Pinto | Drug: Endodontic treatment using Guedes Pinto<br>* Endodontic treatment using Guedes Pinto paste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success or failure of two endodontic treatments | The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. 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. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of the obturation obtained with the two root canal filling pastes | The quality of the filling will be assessed by a blinded examiner according to two criteria. Through an index that ranks the shutter in satisfactory, questionable or unsatisfactory and through evaluation of digital radiographic images with the aid of a computational tool (Autodesk AutoCAD), where the visible areas of the root canal will be measured in previous radiographic examination and their measurements of the area of the root canal filling pastes filled with channels. The influence of the quality of the filling in the successful treatment will also be assessed. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endodontics, Deciduous teeth, Iodoform pastes, Treatment Refusal