Denture Adhesives for Denture Retention

Overseen By Haleon Response Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HALEON

Must not be taking: Bisphosphonates

Disqualifiers: Pregnancy, Substance abuse, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 13 hours

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Participant willing and able to comply with scheduled visits and study procedures

Participant with dentate mandibular arch or stable partial/full denture in the mandibular arch

Participant provision of a signed and dated informed consent document

Exclusion Criteria

Participant who is an employee of the investigational site or immediate family member

Participant who has participated in other studies involving investigational products within 30 days prior to Visit 1 or during study participation

My doctor has not found me fit to join this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single application of denture adhesive or no adhesive, and bite force is measured over 13 hours

13 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Experimental Denture Adhesive 1
• Experimental Denture Adhesive 2
• Experimental Denture Adhesive 3

How Is the Trial Designed?

Group I: Experimental Denture Adhesive 3 Experimental Treatment 1 Intervention

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.

Group II: Experimental Denture Adhesive 2 Experimental Treatment 1 Intervention

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.

Group III: Experimental Denture Adhesive 1 Experimental Treatment 1 Intervention

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.

Group IV: Positive Control Active Control 1 Intervention

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.

Group V: Negative Control Active Control 1 Intervention

Denture adhesive will not be used.

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+