- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839485
Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic
April 17, 2021 updated by: Fausto Medeiros Mendes, University of Sao Paulo
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
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)
98
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sao Paulo, Brazil, 05508-000
- School of Dentistry, University of Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pasta Guedes-Pinto
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:
|
Experimental: Pasta Guedes-Pinto without antibiotic
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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)
April 20, 2021
Last Update Submitted That Met QC Criteria
April 17, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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