A Phase 3 interventional study of Endodontic treatment using Guedes-Pinto Paste and Endodontic using Guedes-Pinto Paste without antibiotic in Pulp Disorder, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of Sao Paulo · Phase 3, Interventional, and Treatment
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.
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.
125 studies on the registry are indexed under Dental Pulp Diseases; 38 are open to participants now.
This study's enrollment of 100 is above the median of 50 across 103 interventional studies indexed under Dental Pulp Diseases.
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Exclusion Criteria:
Teeth presenting one of the following:
Endodontic treatment using Guedes-Pinto Paste
Drug: Endodontic treatment using Guedes-Pinto Paste
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 is applied
Also known as: Pulpectomy with 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 without antibiotic is applied
Also known as: Pulpectomy with Guedes-Pinto paste without antibiotic
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.
Time frame: 1 year
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).
Time frame: 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).
Time frame: 7 days
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).
Time frame: 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).
Time frame: Imediatelly after the treatment
Plan to share: No
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University of Sao Paulo