Poligrip for Denture Retention

Overseen By Haleon Response Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HALEON

Must not be taking: Bisphosphonates

Disqualifiers: Periodontitis, Candida, Caries, Pain conditions, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Poligrip Power Max Hold + Seal denture adhesive in preventing food from getting stuck under dentures. Participants will use their dentures without adhesive for three weeks, followed by three weeks with the adhesive. The trial is open to U.S. residents (excluding Hawaii and Alaska) who regularly wear dentures and self-assess their fit as good. As an unphased trial, it provides participants an opportunity to contribute to understanding the effectiveness of denture adhesives in everyday use.

What prior data suggests that this denture adhesive is safe for use?

Research has shown that Poligrip Power Max Hold + Seal is generally safe as a denture adhesive. Since this product is available in stores, it meets certain safety standards. However, some users have reported minor side effects, such as a burning sensation in the mouth or lips and redness in the mouth. While these side effects are uncommon, awareness is important. If discomfort occurs, consulting a healthcare professional is advisable. Overall, Poligrip is considered safe when used as directed on the label. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Poligrip Power Max Hold + Seal because it offers a potential improvement in denture retention for users who typically rely on traditional denture adhesives. Unlike standard options that may require multiple applications throughout the day, this treatment promises a secure hold with just a single daily application. The innovative formulation aims to enhance the seal and comfort, reducing the likelihood of food particles getting trapped and improving overall user satisfaction. This could be a game-changer for denture wearers seeking more convenience and confidence in their daily lives.

What evidence suggests that Poligrip Power Max Hold + Seal is effective for denture retention?

Research has shown that Poligrip Power Max Hold + Seal effectively keeps dentures in place, securing them for up to 12 hours. Users have reported increased confidence and comfort while using this adhesive. The product also prevents food from getting trapped under dentures, enhancing the eating experience. Overall, users have provided positive feedback about its reliability in daily use. Participants in this trial will first wear their dentures without adhesive and then with Poligrip Power Max Hold + Seal to evaluate its effectiveness. ^{6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for habitual wearers of partial or full dentures, aged 18+, residing in the US (excluding Hawaii and Alaska). They must be in good health, able to follow study procedures, and not have had recent denture adjustments. Those with allergies to materials used in the adhesive or certain medical conditions are excluded.

Inclusion Criteria

Participant must provide a signed and dated informed consent document before any assessment is performed

Participant must be willing and able to comply with all study-related activities

Participant must be a habitual wearer of partial or full denture

Exclusion Criteria

Participants who have received denture-related adjustments during the study

Participant deemed unsuitable by the investigator or delegate

Participant unable to read and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

No Adhesive Use

Participants wear their dentures without any denture adhesive cream for 3 weeks

3 weeks

Daily self-assessment

Adhesive Use

Participants wear their dentures with the denture adhesive cream once daily for 3 weeks

3 weeks

Daily self-assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Poligrip Power Max Hold + Seal

Trial Overview The effectiveness of Poligrip Power Max Hold + Seal, a marketed denture adhesive, is being tested over three weeks. The study compares participants' experiences with food entrapment under their dentures when using the adhesive versus not using it at all.

How Is the Trial Designed?

Group I: No Adhesive Use Followed by Adhesive Use Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+

Citations

1. polident.com polident.com/en-us/products/poligrip-ultimate/

Poligrip Power Max Ultimate All-in-1 Denture Adhesive Poligrip Power Max is an amazing denture adhesive that truly provides 100% strong, all-day hold. It makes my dentures feel completely secure, giving me the ...

2. amazon.com amazon.com/Poligrip-Denture-Adhesive-Secure-Flavor/dp/B09RFHRSD8

Poligrip Power Max Power Hold plus Seal Denture ... Why choose Poligrip Power Hold & Seal? · Protective food barrier · Strongest hold* · Enhance your denture care routine with Polident cleansers.

3. walmart.com walmart.com/reviews/product/966532822

Customer reviews for Poligrip Power Hold + Seal Denture ... I like the PoligripPiwer Max Power Hold seal but notice that it's very soft and has after taste! I wear partials but notice hold as much as the other Polligrip ...

4. haleonhealthpartner.com haleonhealthpartner.com/en-us/oral-health/brands/poligrip/products/power-hold-and-seal/

Poligrip Power Hold + Seal Poligrip provides a statistically significant increase in ratings of confidence and comfort, and is clinically proven to deliver a 12-hour hold.

5. dhpsupply.com dhpsupply.com/msds/360-05450.pdf

SAFETY DATA SHEET Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. Eye contact. 2 / 9. Material name: DENTURE ADHESIVE CREAM.

6. polident.com polident.com/en-us/products/power-hold-plus-seal/

Poligrip Power Hold + Seal Denture Adhesive Poligrip Power Hold + Seal provides our strongest hold within the Poligrip range and a 5x protective food barrier** against food particles. This denture ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=14790942&pc=KOT

MAUDE Adverse Event Report - accessdata.fda.gov The action taken with poligrip power max hold+seal denture adhesive was unknown.On an unknown date, the outcome of the burned mouth, burning lips, oral redness ...

8. amazon.com amazon.com/Poligrip-Denture-Adhesive-Secure-Flavor/dp/B09RG3GQS7

Super Poligrip Power Max Power Hold plus Seal Denture ... One 2.2 oz tube of flavor free Poligrip Power Max Power Hold plus Seal Denture Adhesive Cream, Denture Cream for Secure Hold and Food Seal; Power Max ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07273149

A Study to Assess the Effectiveness of a Marketed Denture ... The purpose of this decentralised study in a real-world setting is to assess the effectiveness of a marketed denture adhesive (Poligrip ...