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

NCT ID: NCT03839485

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-08
• Study Completion Date: 2021-04-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pasta Guedes-Pinto

Endodontic treatment using Guedes-Pinto Paste

Group Type: ACTIVE_COMPARATOR

Endodontic treatment using Guedes-Pinto Paste

Intervention Type: DRUG

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

Pasta Guedes-Pinto without antibiotic

Endodontic using Guedes-Pinto paste without antibiotic

Group Type: EXPERIMENTAL

Endodontic using Guedes-Pinto Paste without antibiotic

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Pulpectomy with Guedes-Pinto paste; Pulpectomy with Guedes-Pinto paste without antibiotic

Eligibility Criteria

Inclusion Criteria

• Primary molar teeth with necessity of endodontic treatment.
• Patients whose parents or guardians consent to their participation in the study

Exclusion Criteria

• Systemic health problems, congenital facial deformities, facial tumors or syndromes
• Teeth presenting one of the following:

• Resorption of more than 2/3 of the root
• Destruction of the crypt of the permanent successor
• Pulp chamber floor drilling.
• Presence of internal resorption

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fausto Medeiros Mendes

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Dentistry, University of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

FouspPGP

Identifier Type: -

Identifier Source: org_study_id