Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03839485
Recruitment Status : Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Fausto Medeiros Mendes, University of Sao Paulo

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.

Layout table for study information
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
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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




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: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, 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 will be between the initial and follow-up radiographs.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839485


Locations
Layout table for location information
Brazil
School of Dentistry, University of Sao Paulo
Sao Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo

Layout table for additonal 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    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents