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Experimental Denture Adhesive

Phase 3

Denture Retention | Small molecule | Other |GSK plc|Last Updated: Sep 5, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment119
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03807700To Evaluate Oral Health and Quality of Life Associated With Use of a Denture AdhesivePHASE3 COMPLETED 119 — — Feb 4, 2019May 4, 2019Sep 5, 20211 Canada
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Study Endpoints
Primary Endpoints
Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 12 Weeks
At Baseline and after 12 weeks

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.

Secondary Endpoints
Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 1, 4 and 8 Weeks
At Baseline and after 1 week, 4 weeks and 8 weeks
Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.
At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeks
Mucosal Health Analysis of Denture Bearing Tissues by Change From Baseline in Mucosal Score Assessment (MSA) After 1, 4, 8 and 12 Weeks
At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Experimental denture adhesiveEXPERIMENTALIn this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.
No adhesiveNO_INTERVENTIONIn this arm, participants will not use any denture adhesive.
Interventions
NameTypeDescription
Experimental Denture AdhesiveDRUGIn this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Canada
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