At a glance
ClinicalIndex Comparison Record- ✓Age 18–84 years inclusive
- ✓Good general and mental health with no clinically significant abnormalities in medical history or oral examination; able to understand and follow study procedures
- ✓Completely edentulous maxillary arch restored with conventional full acrylic-based upper complete denture
- ✓Maxillary denture moderately well-fitting at screening (Kapur Index retention score >2, stability score >2)
- ✕Pregnant, breast-feeding, or intending to become pregnant during the study
- ✕Known or suspected intolerance or hypersensitivity to the study materials or any stated ingredients
- ✕Previous participation in this study or another clinical study within 30 days of screening, or receipt of investigational drug within 30 days
- ✕Recent history (within last year) of alcohol or other substance abuse
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Method Development Clinical Study to Investigate the Efficacy of the Different Frequencies of Use of a Denture Cleanser
In Brief
A clinical study evaluating Denture Cleanser Daily Use Period, Denture Cleanser Weekly Use Period, and 1 other intervention for Denture Cleansers. Completed, enrolled 19 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
One denture cleansing tablet will be soaked in a cup of very warm water (150 ml) with dentures for Day 0 to Day 7 for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.
One denture cleansing tablet will be soaked in cup of very warm water (150 ml) from Day 0 to Day 6 for 15 mins; and in cup of very warm water (150 ml) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.
A cup of very warm water will be used to soak one denture cleansing tablet and dentures for per day (Day 0 to Day 7) or weekly (Day 0 and Day 7) treatment regimen.