NCT03478644

Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe

Clinical Study To Determine The Oral and Dermal Tolerability of an Experimental Denture Wipe

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the consumer acceptability of the denture cleansing wipes was also evaluated via a consumer acceptability questionnaire. A methodology was also evaluated to assess the efficacy of the denture wipe at removing food debris as exploratory objective.

Detailed description

This was a two phase single-center study. Phase 1 (Food removal testing), was monadic and only the wipe treatment was administered to complete upper dentures. Phase 1 participants then progressed to phase 2 (oral soft tissue \[OST\] and dermal assessment) which was an examiner blind parallel group, randomized and stratified (by denture type) design where both treatments (a single wipe and water control) were administered. Phase 2 participants included both fully and partially edentulous adult participants. Participants were not permitted to use any denture cleansers other than those provided and were not permitted to use denture fixatives for the duration of the study. The study comprised a Screening/Baseline visit and a 2 week Treatment Period with visits after 1 and 2 weeks use. Following screening participants who were eligible for Phase 1 were assessed for food migration adequacy. Participants consumed 30-32g (gram) of non-salted peanut halves in a controlled manner, then briefly rinsed their mouth with water and removed their upper denture. The investigator visually assessed the peanut particle migration underneath the denture on a 0-3 scale and those participants with a score greater than 0 were wiped by the participant with the experimental denture wipe. The mass of peanuts removed by the wipe and those remaining on the denture was subsequently measured. For a subset of participants (2 participants per peanut particle migration scale score), their dentures were photographed after peanut consumption both before and after use of the experimental denture wipe. Phase 1 participants then continued into Phase 2. All Phase 2 participants undertook an OST examination and a dermatological assessment of both sides of their lead hand, then randomized. The dental examiner and dermatologist were blinded to the treatment allocation. The results of these assessments served as the baseline reading. Participants were then instructed on the use of their assigned treatment with the first application undertaken and supervised at the study site. Participants were provided with a diary card to record their treatment applications and a consumer acceptability questionnaire to be completed at the time of their first at home treatment use. Participants were also provided with denture cleansing tablets for use overnight for the duration of the study in order to maintain denture hygiene. Participants returned to the study site after 7±3 and 14±3 days use of product for repeat OST and dermatological assessments.

Conditions

• Denture Cleansers

Interventions

Type	Name	Description
DEVICE	Experimental Denture Wipe	Participants were instructed to use the experimental wipe to clean their dentures, external to their mouth, up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days. Participants were instructed to use one wipe per denture.
OTHER	Tap Water	Participants were instructed to use running tap water to clean their dentures up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days.

Timeline

• Start date: 2016-10-10
• Primary completion: 2016-10-31
• Completion: 2016-10-31
• First posted: 2018-03-27
• Last updated: 2018-10-15
• Results posted: 2018-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study