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

• ClinicalTrials.gov Identifier: NCT03839485
• Recruitment Status: Completed
• First Posted: February 15, 2019
• Last Update Posted: April 20, 2021
• Sponsor: University of Sao Paulo
• Information provided by (Responsible Party): Fausto Medeiros Mendes, University of Sao Paulo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulp Disorder	Drug: Endodontic treatment using Guedes-Pinto Paste; Drug: Endodontic using Guedes-Pinto Paste without antibiotic	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Both materials will be packed in identical and opaque syringes, identified only with letters (A and B). The codes will be revealed only at the end of the study. Neither the professional who will be performing the treatment, nor the patient or the evaluator, who will perform the exams at follow-up times, will know which of the two materials of choice were selected for each tooth, characterizing the study as triple-blind.
• Primary Purpose: Treatment
• Official Title: Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic: Randomized Non-inferiority Clinical Trial
• Actual Study Start Date: June 8, 2018
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: April 10, 2021

Arms and Interventions

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 Name: 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 Name: Pulpectomy with Guedes-Pinto paste without antibiotic

Outcome Measures

Primary Outcome Measures :

1. Success or failure of treatment [ Time Frame: 1 year ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Brazil

School of Dentistry, University of Sao Paulo

Sao Paulo, Brazil, 05508-000

Sponsors and Collaborators

University of Sao Paulo

More Information

• Responsible Party: Fausto Medeiros Mendes, Principal investigator, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT03839485
• Other Study ID Numbers: FouspPGP
• First Posted: February 15, 2019
• Last Update Posted: April 20, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fausto Medeiros Mendes, University of Sao Paulo:

pulpectomy; primary teeth; root canal filling materials

Additional relevant MeSH terms:

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Anti-Bacterial Agents; Antibiotics, Antitubercular; Anti-Infective Agents; Antitubercular Agents