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

Fausto Medeiros Mendes

Status and phase: Completed; Phase 3

Conditions: Endodontic Treatment of Primary Teeth

Treatments: Drug: Endodontic treatment using Vitapex; Drug: Endodontic treatment using Guedes Pinto

Study type: Interventional

Funder types: Other

Identifiers

NCT02216942

FOUSP2408

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 104 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

Vitapex

Active Comparator group

Description:

Endodontic treatment using Vitapex

Treatment:

Drug: Endodontic treatment using Vitapex

Guedes Pinto Paste

Experimental group

Description:

Endodontic treatment using Guedes Pinto

Treatment:

Drug: Endodontic treatment using Guedes Pinto