NCT07273149

A Study to Assess the Effectiveness of a Marketed Denture Adhesive in Real-World Setting

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Denture Retention

Interventions

Type	Name	Description
DEVICE	Poligrip Power Max Hold + Seal	Poligrip Power Max Hold + Seal denture adhesive cream containing sodium-calcium mixed partial salt of poly(methylvinylether/maleic acid) and carboxymethylcellulose.

Timeline

• Start date: 2025-12-05
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-12-09
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study