Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03839485
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2019-02-11
Brief Title:
Endodontic Treatment of Primary Teeth with Guedes-Pinto Paste Without Antibiotic
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Endodontic Treatment of Primary Teeth with Guedes-Pinto Paste Without Antibiotic Randomized Non-inferiority Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 120 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None