NCT03839485

Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic

Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic: Randomized Non-inferiority Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

Summary

The pulp therapy in primary teeth is still necessary even with all odontopediatrics evolution in prevention and minimal intervention, aiming to keep the tooth free of inflammation or infection and in a functional state until its exfoliation. Several materials are used as filling paste of primary teeth. In Brazil, the Guedes-Pinto Paste (PGP), an association of iodofórmio, camphorated paramonochlorophenol, prednisolone and rifamycin, has been widely used for some decades. However, current Brazilian legislation has made it difficult to commercialize antibiotics, which has made it difficult to obtain the ointment that is the association between prednisolone and rifamycin. Therefore, the objective of this clinical trial will be to test PGP without rifamycin in the pulpectomy of primary teeth, and to compare it with the treatment performed with conventional PGP.

Detailed description

A randomized triple-blind non-inferiority clinical study with two parallel arms, with a 12-month follow-up, will be performed. The experimental group will be PGP formulated without the antibiotic, while the control group is the conventional PGP, containing rifamycin. The conventional pulpectomy will be performed using manual files, performing the instrumentation aided by Endo-PTC and 1% sodium hypochlorite. At the end of the instrumentation, just before the obturation, the groups will be drawn, with the strategy of randomization in permuted blocks and stratified by the initial condition of the tooth (with or without periapical lesion). The main outcome will be the clinical and radiographic success of endodontic treatment after 12 months. Patients who seek the dental service of the municipality and require endodontic treatment will be invited to participate in the study. The data will be statistically analyzed using the statistical package Stata 12.0 (Stata Corporation, College Station, TX, USA). The longevity of the treatments will be evaluated by estimating survival rates using the Kaplan-Meier method. The differences between survival rates according to the type of endodontic treatment proposed will be analyzed through the Log-rank test.

Conditions

• Pulp Disorder

Interventions

Type	Name	Description
DRUG	Endodontic treatment using Guedes-Pinto Paste	Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste is applied
DRUG	Endodontic using Guedes-Pinto Paste without antibiotic	Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste without antibiotic is applied

Timeline

• Start date: 2018-06-08
• Primary completion: 2019-06-30
• Completion: 2021-04-10
• First posted: 2019-02-15
• Last updated: 2025-03-28

Locations

1 site across 1 country: Brazil