Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Experimental Denture Adhesive · 1 trial · 1 indication
Gum comfort questionnaire was referred to assess the gum health of the denture wearer and to compare the ability of an experimental denture adhesive to provide self-perceived mucosal benefits compared to the use of no adhesive after 12 weeks of product use. It was comprised of 5 questions- Q1: My gums feel comfortable when wearing my denture(s), Q2: I feel my gums are cushioned from the impact of chewing and biting; Q3: My gums do not feel sore at the end of the day; Q4: My gums are not irritated by trapped food particles under my denture(s); Q5: My gums do not feel tired at the end of the day. The participants recorded the response on scale of 0-4: 0-Agree Strongly, 1-Agree Somewhat, 2-Neither Agree or Disagree, 3-Disagree Somewhat, 4- Disagree Strongly). Total score range is 0-20 where lower score indicated better results.
| Arm | Type | Description |
|---|---|---|
| Experimental denture adhesive | EXPERIMENTAL | In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth. |
| No adhesive | NO_INTERVENTION | In this arm, participants will not use any denture adhesive. |
| Name | Type | Description |
|---|---|---|
| Experimental Denture Adhesive | DRUG | In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth. |
Inclusion Criteria: 1. Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. 2. A participant who is willing and able to comply with scheduled visits, treatmen...
Experimental Denture Adhesive is used for denture retention, helping to keep dentures securely in place. It is being developed by GSK plc (GSK) as a small molecule treatment for individuals who wear dentures and need improved retention and stability.
GSK plc (GSK) is developing Experimental Denture Adhesive. The company is conducting clinical research on this product for denture retention, with the goal of improving oral health and quality of life for denture wearers.
Experimental Denture Adhesive is in Phase 3 clinical development. It is an investigational product and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its effects on denture retention.
Experimental Denture Adhesive has one completed clinical trial, NCT03807700, titled 'To Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive.' This Phase 3 study enrolled 119 participants in Canada and was a randomized, no-treatment controlled trial.
Experimental Denture Adhesive is not FDA approved. It is an investigational product currently in Phase 3 clinical development. The completed trial NCT03807700 evaluated its use for denture retention, but regulatory approval has not been granted.