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

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.

Study Overview

• Status: Completed
• Conditions: Pulp Disorder
• Intervention / Treatment: Drug: Endodontic treatment using Guedes-Pinto Paste; Drug: Endodontic using Guedes-Pinto Paste without antibiotic

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-000
    • School of Dentistry, University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pasta Guedes-Pinto; Endodontic treatment using Guedes-Pinto Paste	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; Other Names: Pulpectomy with Guedes-Pinto paste
Experimental: Pasta Guedes-Pinto without antibiotic; Endodontic using Guedes-Pinto paste without antibiotic	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; Other Names: Pulpectomy with Guedes-Pinto paste without antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success or failure of treatment	The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: no occurrence of a periapical rarefaction in the furcation area; reduction or maintenance of an already present bone rarefaction in the furcation area of posterior teeth, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions, we will compare the initial and final radiographs. Despite the anticipated time frame of 1 year, some participants were evaluated after this period due to the pandemic. The follow-up periods were until 24 months, and the final analysis were adjusted for this protocol deviation.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative fistula	Report of fistula or presence of pus on the area of the endodontic treatment. This variable was recorded through a phone call to the children's guardians, who answered if they had noticed any purulent secretion in the area of the endodontically treated tooth (yes or no - dichotomous variable).	7 days
Post-operative pain	Report of post-operative pain until 7 days after the procedure. This outcome was collected through a phone call with the children's guardians, who asked if their child had reported any pain in the area of the procedure and if the participant had taken an analgesic (yes or no - dichotomous variable).	7 days
Quality of root canal filling	This variable was evaluated in the radiographs taken immediately after the endodontic treatment. An external observer, blinded to the allocated group, classified the quality of the root canal filling in adequate (filling to within 1 mm of the radiographic apex), before the apex (more than 1 mm of the radiographic apex) or with filling material overflow. This is a nominal qualitative variable (3 categories).	Imediatelly after the treatment
Post-operatve oedema	Report of post-operative oedema on the area of the endodontic treatment. This variable was recorded through a phone call to the children's guardians, who answered if they had noticed any oedema or swelling in the area of the endodontically treated tooth (yes or no - dichotomous variable).	7 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): April 10, 2021

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: primary teeth; pulpectomy; root canal filling materials
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: FouspPGP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No