Procedures
fits, denture, Denture
ADVERSE EVENTS, INFILTRATION, CREST
At the screening visits for both studies, participants underwent an oral soft tissue (OST) examination and were assessed for denture retention and stability. Participants were also assessed for adequate food migration under the dentures whereby they chewed and consumed a 30–32 g serving of peanuts in individual portions of approximately eight peanut halves at a time. Participants then rinsed their mouths with water for up to 10 s to help remove any peanut particles that had not migrated under the dentures. Visual assessment of the amount and degree of peanut particle migration under the dentures was conducted and graded accordingly by the examiner using a 4‐point scale from 0 (no peanut migration) to 3 (extensive peanut migration on the crest of the denture). To ensure only participants who experienced peanut particle infiltration were included in the study, participants with a score of 1–3 were randomized to the treatment sequence in which they would receive each condition according to a predetermined schedule generated by an independent statistical agency.For the pilot study, a marketed denture adhesive (Super Poligrip® Free Denture Adhesive Cream containing polymethylvinyl ether/maleic acid; sodium–calcium mixed partial salt, petrolatum, cellulose gum, mineral oil; Haleon, Weybridge, UK; USA marketplace) was applied using a preloaded syringe at a dose of 1.0 g to the maxillary denture and 0.6 g to the mandibular denture when participants were randomized to the denture adhesive treatment arm. The treatment groups were as follows:
Conventional pattern application: Continuous strips pattern application: No adhesive.For the efficacy study, eligible participants were randomized (1:1) to one of two study groups in a crossover manner to first receive either:
Test adhesive (COREGA Máximo Sellado/Selamento containing sodium–calcium mixed partial salt of polymethylvinyl ether/maleic acid, carboxymethylcellulose, petrolatum, mineral oil; Haleon) applied as detailed above in the continuous strips pattern via the precision nozzle incorporated into the primary packaging for a total dose of 1.0 g (±0.1 g) for the mandibular denture, and 0.6 g (±0.1 g) for the maxillary denture.No adhesive.For both studies, the amount of adhesive applied to the denture was controlled by weighing the adhesive to be placed onto the denture. The amounts used (1.0 g to the maxillary and 0.6 g to the mandibular denture) were chosen to be representative of the amounts typically used in practice.For both studies, during treatment visits, the use of any nicotine or nicotine‐containing products, or any other oral healthcare products other than the study products was prohibited while at the study site.On test days, participants underwent an OST examination, and dentures were cleaned and dried before adhesive application/denture insertion; participants rinsed their mouth with water and expectorated before denture insertion. Adhesive/no adhesive was applied (per randomization schedule) and dentures were placed in the mouth; then the participant pressed the denture firmly in place and bit down for a few seconds to secure the hold. At 60 (±5) min after denture insertion, each participant was given a standardized portion of peanuts (30–32 g) to consume following a prescribed chewing and swallowing method whereby participants sequentially chewed approximately eight peanut halves for at least 20 s before swallowing. Participants were allowed small sips of water during peanut consumption to aid chewing and swallowing. They were provided with a tick‐box sheet and instructed to record each incident of denture dislodgement (of either denture) that occurred while chewing the peanuts.After peanut consumption, participants gently rinsed their mouths with water for 5 s in the pilot study. This rinsing step was increased to 10 s for the follow‐on efficacy study as it was discovered that 5 s was not sufficient to remove all residual peanut particles from around the mouth that had not been retained under the dentures. The examiner removed any peanut particles from the vestibular and sublingual areas (maxillary and mandibular), then carefully extracted the mandibular denture. They then removed and collected any peanut particles and residual adhesive, first from the lower edentulous ridge using gauze, then the maxillary denture. Respective gauzes for each denture were retained in separate, marked beakers.Any residual peanut particles present on the denture surface other than those on the intaglio surface were discarded. In each study, with approximately five participants per group, the denture intaglio surface was photographed such that a variety of denture sizes and fits were represented. These images were for visualization purposes only and were not analyzed.Maxillary and mandibular dentures, together with their corresponding gauze, were placed in separate beakers of warm deionized (DI) water and sonicated for at least 30 min to loosen adhering peanut particles. Any peanut pieces remaining on the prosthesis or gauze were then rinsed out into the beaker with fresh DI water. The gauze pieces were discarded and the dentures were cleaned and returned to the participant. The contents of the beaker (water, adhesive, saliva, and peanut particles) were heated to boiling with frequent stirring to facilitate the dissolution of any remaining adhesive and then strained through a standard #60 testing sieve. The remaining peanut particles were repeatedly washed with hot DI water to remove residual saliva and contaminants, air‐dried overnight, then oven dried for 5 h at 40°C. Once cooled, the mass (mg) of the dry peanut particles that had migrated under each denture was determined.In both studies, following food infiltration testing and denture removal on test days, participants completed a questionnaire on their experience during chewing and whether they had been aware of peanut particles under their dentures (Yes/No answer). Participants who answered “yes” completed additional questions relating to their subjective assessment of the amount of peanut particles under the dentures (1 = none to 10 = numerous), and how bothered they were by these (1 = not at all bothered to 10 = extremely bothered). Additionally, in the pilot study, participants rated how irritating the peanut particles were (1 = not at all irritating to 10 = extremely irritating).Safety was assessed by OST examination at screening and before/after each assessment at the treatment visits, through a collection of adverse events (AEs) and medical device incidents. Abnormalities and AEs reported after the participant's first use of treatment were considered treatment‐emergent adverse events (TEAEs).