Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 4:54 AM
Study NCT ID:
NCT04532060
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2020-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
Sponsor:
São Paulo State University
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
Status:
COMPLETED
Status Verified Date:
2020-08
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:
Objective: This randomized clinical trial assessed antimicrobial Photodynamic Therapy (aPDT) mediated by Photodithazine (PDZ) to treat patients with denture stomatitis (DS). Methodologies: Patients with DS were randomly assigned to the groups: aPDT (n=30) and nystatin (NYS, n=35). aPDT patients received 6 aPDT sessions, three times a week for 15 days, which involved PDZ (200 mg/L) topical application (20 min) on the palate and upper denture, followed by light emitting diode (LED) illumination (660 nm, 50 J/cm²). NYS patients were instructed to rinse one dropper of this medication for one minute, four times a day, for 15 days. Microbiological collections of dentures and palates were performed and cultured on blood agar and CHROMAgar Candida. Microbial viability was determined, and photographs of the palates were taken for clinical evaluation. Data were analyzed by Repeated Measure Linear Model and Bonferroni (p≤0.05).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: