A Decentralised, Open-labelled, Clinical Study to Assess the Effectiveness of a Marketed Denture Adhesive in Food Occlusion in Denture Wearers in a Real-world Setting
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- HALEON
- Enrollment
- 375
- Locations
- 2
- Primary Endpoint
- Mean Score of the Food Occlusion Question Assessed Using the Numerical Rating Scale (NRS)
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participant's provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- •Participants from all genders (male, female, not specified).
- •Participant who, at the time of screening is 18 years old and above.
- •Participants who are willing and able to comply with all study related activities as shown in the schedule of activities, study restrictions, and other study procedures.
- •A participant in good general and mental health with no self-reported clinically significant or relevant abnormalities in medical history or upon a previous oral examination, or condition, that would impact on the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- •A participant who is a habitual wearer of partial or full denture defined as participant who wear their dentures for the majority of their time whilst awake.
- •Participants should have a relatively well-fitted denture (self-assessed).
- •Participants who reside in the United States (except for Hawaii and Alaska).
Exclusion Criteria
- •An employee either directly involved in the conduct of the study or a member of their immediate family; or an employee of Lindus Health otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
- •A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •A participant who has been previously enrolled in this study.
- •Participants who have a clinical condition as self-reported on the screening questionnaire, which include:
- •Participants who have undergone treatment for periodontal or gum disease within 6 months of screening or are currently undergoing treatment for periodontal or gum disease.
- •Participants who have been informed by Health Care Professional (HCP) that they have active periodontitis.
- •Participants who have been informed by HCP that they have active candida infection.
- •Participants who have been informed by HCP that they have active caries.
- •Participants with any chronic and/or severe painful health condition(s) which lead to regular use of pain relief medications more than 3 days a week.
- •Participants who have any clinically significant or relevant oral abnormality (example, temporomandibular joint problems) or palate problem that could have impact on their participation in the study.
Arms & Interventions
No Adhesive Use Followed by Adhesive Use
Participants will wear their dentures without any denture adhesive cream for 3 weeks from Day 1 to Day 21 of the study. Participants will wear their dentures with the denture adhesive cream (Poligrip Power Max Hold + Seal) as per the label instructions, once daily for 3 weeks from Day 22 to Day 42 of the study.
Intervention: Poligrip Power Max Hold + Seal (Device)
Outcomes
Primary Outcomes
Mean Score of the Food Occlusion Question Assessed Using the Numerical Rating Scale (NRS)
Time Frame: Up to Week 6
Participants will answer specific food related question on a daily basis throughout the study. Participants scored the Food Occlusion Question using the NRS.
Secondary Outcomes
- Mean Daily Responses of Full-day Food Occlusion Question(Up to Week 6)
- Mean Food Particle Bothersomeness Score of Food Occlusion Question Assessed Using the NRS(Up to Week 6)
- Mean Comfort Score of Food Occlusion Question Assessed Using the NRS(Up to Week 6)