Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe
Condition: Denture Cleansers
Study type: Interventional

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.
    

Intervention name(s): Experimental Denture Wipe; Tap Water
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Device Feasibility