Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-10 @ 8:13 PM
Study NCT ID:
NCT02887456
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2016-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste - Protocol of a Phase 2 Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-08
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 maintenance of primary teeth until their exfoliation has been one of the main purposes of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to conduct a randomized clinical trial is to evaluate the performance of endodontic treatment in primary teeth using MTA paste, comparing to Vitapex.
Detailed Description:
After approval by the ethics committee of the patients Faculty of Dentistry, University of São Paulo that having root canal filling of primary teeth will be invited to participate in the study. A clinical examination and prior radiographic diagnosis will be-held. The patient will be randomized to one of two groups and will be made the endodontics by a dentist. The patient will be accompanied with periods of one week, one month and three months by a blinded evaluator. The outcome will be the success or failure of endodontic treatments evaluated through permanent tooth in the arch on clinical and radiographic conditions of normality. The longevity of the treatments will be evaluated by estimating survival rates by Kaplan-Meier. The differences between the survival rates according to the type of proposed endodontic treatment will be analyzed using the log-rank test with a minimum significance level of 5%.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: