NCT02780661

Frequency of Denture Cleanser Use and Denture Cleanliness

A Method Development Clinical Study to Investigate the Efficacy of the Different Frequencies of Use of a Denture Cleanser

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

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.

Conditions

• Denture Cleansers

Interventions

Type	Name	Description
DEVICE	Denture Cleanser Daily Use Period	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.
DEVICE	Denture Cleanser Weekly Use Period	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.
OTHER	Water	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.

Timeline

• Start date: 2016-06-20
• Primary completion: 2016-11-15
• Completion: 2016-11-15
• First posted: 2016-05-23
• Last updated: 2018-12-24
• Results posted: 2018-08-10

Locations

1 site across 1 country: United Kingdom