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Experimental Denture Adhesive 2 for Denture Retention
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at 0.5, 1, 3, 6 and 9 hours
Awards & highlights
Study Summary
The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, at 0.5, 1, 3, 6 and 9 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at 0.5, 1, 3, 6 and 9 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force
Secondary outcome measures
Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Denture Adhesive 2Experimental Treatment1 Intervention
A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.
Group II: Experimental Denture Adhesive 1Experimental Treatment1 Intervention
A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.
Group III: Negative ControlActive Control1 Intervention
Denture adhesive will not be used.
Group IV: Positive ControlActive Control1 Intervention
A single application of 1 gram of Super Poligrip Free denture adhesive will be applied topically to oral tissues via the upper denture.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental Denture Adhesive 1
2022
Completed Phase 3
~50
Experimental Denture Adhesive 2
2022
Completed Phase 3
~50
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,427 Total Patients Enrolled
7 Trials studying Denture Retention
368 Patients Enrolled for Denture Retention
HALEONLead Sponsor
27 Previous Clinical Trials
3,691 Total Patients Enrolled
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