The purpose of this decentralised study in a real-world setting is to assess the effectiveness of a marketed denture adhesive (Poligrip Power Max Hold + Seal) in preventing food entrapment under dentures (self-assessed). The study will evaluate participants perceived food occlusion of a marketed denture adhesive over three weeks compared to no adhesive use over three weeks in a real-world setting.
This will be an open-labelled, decentralised, 6-week study to assess the effectiveness of food occlusion of a marketed denture adhesive in healthy partial and/or full denture wearers aged 18 and above in a real-world setting. Study comprises of 3 weeks of no adhesive use (Day 1 to 21) followed by 3 weeks of adhesive use (Day 22 to 42). Participants will complete Daily Food Occlusion Questions for 3 weeks without using adhesive cream and another 3 weeks with using adhesive cream. Sufficient participants will be screened to enroll approximately 375 participants to ensure that around 300 of these participants will successfully complete the entire study. Participants will be recruited through digital platforms through pre-screening questionnaires followed by a screening virtual visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
375
Poligrip Power Max Hold + Seal denture adhesive cream containing sodium-calcium mixed partial salt of poly(methylvinylether/maleic acid) and carboxymethylcellulose.
Lindus Health (virtual site)
Boston, Massachusetts, United States
RECRUITINGMean Score of the Food Occlusion Question Assessed Using the Numerical Rating Scale (NRS)
Participants will answer specific food related question on a daily basis throughout the study. Participants scored the Food Occlusion Question using the NRS.
Time frame: Up to Week 6
Mean Daily Responses of Full-day Food Occlusion Question
Participants will answer the Food Occlusion Question related to occlusion of food particles under denture using a Yes/No response.
Time frame: Up to Week 6
Mean Food Particle Bothersomeness Score of Food Occlusion Question Assessed Using the NRS
Participants will answer specific food related question on a daily basis throughout the study using the NRS.
Time frame: Up to Week 6
Mean Comfort Score of Food Occlusion Question Assessed Using the NRS
Participants will answer specific food related question on a daily basis throughout the study using the NRS.
Time frame: Up to Week 6
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