Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic
Condition: Pulp Disorder
MeSH terms: Dental Pulp Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Endodontic treatment using Guedes-Pinto Paste; Endodontic using Guedes-Pinto Paste without antibiotic
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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 intervention name(s): Pulpectomy with Guedes-Pinto paste; Pulpectomy with Guedes-Pinto paste without antibiotic
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pulpectomy; primary teeth; root canal filling materials