Overview

This trial is active, not recruiting.

Condition endodontic treatment of primary teeth
Treatments endodontic treatment using vitapex, endodontic treatment using guedes pinto
Phase phase 3
Sponsor Fausto Medeiros Mendes
Start date January 2015
End date July 2015
Trial size 98 participants
Trial identifier NCT02216942, FOUSP2408

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Endodontic treatment using Vitapex
endodontic treatment using vitapex
Endodontic treatment using Vitapex
(Experimental)
Endodontic treatment using Guedes Pinto
endodontic treatment using guedes pinto
Endodontic treatment using Guedes Pinto paste

Primary Outcomes

Measure
Success or failure of two endodontic treatments
time frame: two years

Secondary Outcomes

Measure
Quality of the obturation obtained with the two root canal filling pastes
time frame: two years

Eligibility Criteria

Male or female participants from 1 year up to 12 years old.

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

Additional Information

Official title Endodontic Treatment of Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial
Principal investigator Carmela Bresolin, PHD student
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 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%.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.