Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-31 @ 8:52 AM
Study NCT ID:
NCT02780661
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Frequency of Denture Cleanser Use and Denture Cleanliness
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Method Development Clinical Study to Investigate the Efficacy of the Different Frequencies of Use of a Denture Cleanser
Status:
COMPLETED
Status Verified Date:
2018-12
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:
This method development study will be a two treatment arm, randomized, cross over study in a population with edentulous upper arch restored with a maxillary complete denture. The lower may be a partial or full edentulous mandibular arch that may be restored with a stable complete, partial or implant supported denture.
Detailed Description:
This is a single-center, 2 treatment periods, examiner-blind, randomized, 7 day crossover study in adult participants with a complete maxillary denture. This is a method development study to investigate the changes in the level of denture plaque, microbial counts, microbial composition and stain on the maxillary dentures after daily denture cleanser use versus dentures that are cleaned weekly.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: