This trial is active, not recruiting.

Condition teeth, endodontically-treated
Treatments endodontic treatment using vitapex, endodontic treatment using mta paste
Phase phase 2
Sponsor University of Sao Paulo
Start date September 2016
End date June 2017
Trial size 39 participants
Trial identifier NCT02887456, EndoMTA


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.

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, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Endodontic treatment using Vitapex
endodontic treatment using vitapex
Endodontic treatment using Vitapex
Endodontic treatment using MTA paste
endodontic treatment using mta paste
Endodontic treatment using MTA paste

Primary Outcomes

Success or failure of endodontic treatments
time frame: 3 months

Eligibility Criteria

Male or female participants from 3 years up to 7 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 Using Mineral Trioxide Aggregate Paste - Protocol of a Phase 2 Randomized Clinical Trial
Principal investigator Carmela Bresolin
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%.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.