60 Participants NeededMy employer runs this trial

Denture Adhesives for Denture Retention

HR
Overseen ByHaleon Response Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three new denture adhesive creams to evaluate their effectiveness in keeping dentures in place for 13 hours. Participants will use one of the new adhesives, a standard product, or no adhesive at all. The goal is to determine which adhesive best secures dentures. Individuals with a full set of upper dentures and stable lower dentures or teeth may qualify for this trial. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance denture adhesives for everyone.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking a bisphosphonate drug, you cannot participate. Also, if your medication might interfere with the study, the investigator may decide you should not participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that there isn't enough published data to clearly link denture adhesives, like those under testing, to injuries or side effects. However, many people find these products easy to use. For instance, one study found that 80% of users reported it was "very easy" or "extremely easy" to remove dentures with similar adhesives.

For the second adhesive under testing, some lab studies have shown that denture creams can harm certain cells in the mouth. However, these results come from lab tests, not real-life use. Safety instructions for these products advise avoiding contact with skin and eyes, which is common advice for many consumer products.

The third adhesive carries similar safety notes. Warnings exist about possible risks from excessive use, such as swallowing too much, which can cause issues like blockages. These concerns are typical for many denture creams and do not indicate a special risk with these new formulas.

Overall, these adhesives are being tested to ensure they are safe and effective for daily use. Following the instructions and not exceeding the recommended amount is always advisable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these experimental denture adhesives because they could offer improved denture retention compared to current options like commercially available adhesives. Each of the three new adhesives is designed to provide a strong and lasting bond with just a single application, potentially offering more convenience and reliability for users. Unlike existing products, which might vary in consistency or hold time, these adhesives are being tested for their unique formula that could enhance comfort and confidence for denture wearers. If successful, these adhesives could significantly improve the daily experience for those using dentures.

What evidence suggests that this trial's denture adhesives could be effective for denture retention?

This trial will compare the effectiveness of different denture adhesives. Research has shown that denture adhesives can prevent dentures from becoming loose. Participants may receive Experimental Denture Adhesive 1, which studies found reduces the frequency of denture slippage compared to using no adhesive. Another group will receive Experimental Denture Adhesive 2, which has been shown to keep dentures more secure and stable than using no adhesive. A third group will receive Experimental Denture Adhesive 3, which also improves denture stability and bite strength compared to using no adhesive. Overall, these adhesives help keep dentures in place better than not using any adhesive.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who have a full upper denture and either natural or stable dentures in the lower jaw. Participants must be generally healthy, able to follow study instructions, and not allergic to any of the adhesive ingredients.

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
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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.
See 8 more

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

Trial Overview

The study compares three new experimental denture adhesives and Poligrip Power Hold + Seal against using no adhesive, to see which works best at keeping dentures secure over 13 hours.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Denture Adhesive 3Experimental Treatment1 Intervention
Group II: Experimental Denture Adhesive 2Experimental Treatment1 Intervention
Group III: Experimental Denture Adhesive 1Experimental Treatment1 Intervention
Group IV: Positive ControlActive Control1 Intervention
Group V: Negative ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials
40
Recruited
6,000+

Citations

Comparative Analysis of Adhesive Retention and Denture ...

The aim of this study was to compare the retentive strengths of various forms of denture adhesives (paste, powder, and strips) on different types of mandibular ...

The effectiveness of adhesives on the retention ...

The purpose of this study was to develop a novel, quantitative and more accurate model to test the effect of adhesives on the retentive force of mandibular free ...

Retention Capacity of Original Denture Adhesives and ...

The objective of this study was to compare the effectiveness of original brand DAs and white brands in their retention of conventional complete dentures.

Comparative effectiveness of types of denture adhesives in ...

Cream adhesives significantly improved retention of dentures as assessed by the reduced number of denture dislodgments (RR = -5.35[95%CI: -9.93, ...

Changes in denture retention with denture adhesives and oral ...

Immediately after use, denture adhesive for dry mouth exhibited high retentive force, but retention gradually decreased due to its water content ...

A proof‐of‐principle bite force study using two experimental ...

The majority of participants reported that it was “very easy” or “extremely easy” to remove the denture with Test Adhesive 1 (80.0%; 16/20) and Test Adhesive 2 ...

NCT01712802 | Multicenter Study of Denture Adhesive

Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

Biocompatibility of Denture Adhesives: Effects on Oral Tissues ...

Research has shown that various microorganisms can thrive in these adhesives, potentially affecting both oral and overall health. 3.2. Microbial ...

Denture Adhesives

Neither published data nor FDA adverse event surveillance data are adequate to associate injuries with specific device types or brands. The FDA ...

White paper on guidelines for the use of denture adhesives ...

Other MSDS suggest that continual swallowing of excessive adhesives can lead to oesophageal or bowel obstruction. Denture adhesives are available on the market ...