Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413836
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-09
Brief Title:
Evaluation of Photodynamic Therapy in Pieces With Presence of Fistula
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Effect of the Photodynamic Therapy Mediated by Methylene Blue in Surfactant Medium as an Adjuvant in the Treatment of Parts With Apical Periodontitis and the Presence of Fistula A Randomized Controlled Double-blind Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
aPDT
Brief Summary:
The goal of this clinical trial is to learn if adjuvant antimicrobial photodynamic therapy aPDT can help in the treatment in patients with pieces with apical periodontitis and the presence of fistula in terms of reducing symptoms resolution of fistula and the clinical signs of inflammation at the oral mucose as well as evaluation radiographic parameters
Participants will undergo conventional endodontic treatment at Group I n15 and will undergo conventional endodontic treatment combined with antimicrobial photodynamic therapy at Group IIn15
Participants will undergo conventional endodontic treatment at Group I n15 and will undergo conventional endodontic treatment combined with antimicrobial photodynamic therapy at Group IIn15
Detailed Description:
The calculation of the sample size was conducted with the statistical software G-Power 31 applying the chi-square homogeneity test Identical sample sizes were considered for the aPDT group and the sham group The percentage of type error was set at 5 and the statistical power at 80 obtaining n 30 considering 10 losses The distribution of data within each group and the homogeneity of the variants will be verified for the choice of an analysis of variance or not With this information the most proper statistical test will be conducted The sample size calculation is based on the literature and a 5 significance level will be adopted
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