A Clinical Study to Assess the Effectiveness of Use of Three Experimental Denture Adhesives Compared to Using No-Adhesive

Conditions

• Denture Retention

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Experimental Denture Adhesive 1 — DEVICE
  Denture adhesive cream
• Experimental Denture Adhesive 2 — DEVICE
  Denture adhesive cream
• Experimental Denture Adhesive 3 — DEVICE
  Denture adhesive cream
• Poligrip Power Hold + Seal — DEVICE
  Denture adhesive cream

Study Details

The aim of the proposed clinical study is to investigate the efficacy of three experimental denture adhesive creams to improve denture hold over a period of 13 hours.

Key Dates

Start date

Mar 30, 2026

Status verified

Apr 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Experimental Denture Adhesive 1
  A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically, and participants will be instructed to press dentures into place, hold firmly, and bite down for a few seconds to secure hold.
• Experimental: Experimental Denture Adhesive 2
  A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically, and participants will be instructed to press dentures into place, hold firmly, and bite down for a few seconds to secure hold.
• Experimental: Experimental Denture Adhesive 3
  A single application of 1 gram of Experimental Denture Adhesive 3 will be applied topically, and participants will be instructed to press dentures into place, hold firmly, and bite down for a few seconds to secure hold.
• Active Comparator: Positive Control
  A single application of 1 gram of marketed product will be applied topically, and participants will be instructed to press dentures into place, hold firmly, and bite down for a few seconds to secure hold.
• No Intervention: Negative Control
  Denture adhesive will not be used.

Primary Outcome Measure

Area Over Baseline (AOB) in Bite Force Over 13 Hours (AOB0-13) to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Versus [Vs] No Denture Adhesive) [ Time Frame: Baseline and up to 13 hours ]

Central Contacts

• Haleon Response Center
  +441932 95 95 00
  [email protected]

Locations (1)

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