N/A
N=83
Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress
Denture Retention
Bottom Line
View on ClinicalTrials.gov: NCT02928380 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use — 0.06; 0.08 gram (g) — p=0.0987
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental Denture Adhesive (Device); Reference (Marketed) Denture Adhesive (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use |
0.06; 0.08 | 0.0987 |
| SECONDARY Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use |
0.07; 0.08 | — |
| SECONDARY Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive |
0.07; 0.06 | — |
| SECONDARY Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability |
8.67; 8.84; 8.35; 7.42; 8.11; 6.36 | — |
| SECONDARY Kapur (Olshan Modification) Index Scores for Denture Retention |
4.80; 4.90; 4.63; 4.05; 4.43; 3.46 | — |
| SECONDARY Kapur (Olshan Modification) Index Scores for Denture Stability |
3.88; 3.94; 3.72; 3.37; 3.67; 2.90 | — |
Summary
In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive.
Eligibility Criteria
Inclusion Criteria
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged between 18 and 85 years inclusive
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee:No clinically significant and relevant abnormalities of medical or physical history; Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures
- A qualifying full denture in both the upper and lower arch
- Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6)
- Dentures are well made (according to the well-made assessment)
- Participants must report that they get food trapped under their denture
- A peanut particle migration rating >0 for both dentures at screening
Exclusion Criteria
- Women who are known to be pregnant (participant-reported) or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Medications, which in the opinion of the investigator, would interfere with the conduct of the study
- Taking or have taken a bisphosphonate drug for treatment of osteoporosis
- A serious chronic disease requiring hospitalization
- History of swallowing difficulties or choking
- Any condition not previously mentioned that in the investigator's opinion may impair the study evaluation
- Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Known allergy to peanuts or any other nut
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last year) of alcohol or other substance abuse
- OST examination findings such as stomatitis, open sores, lesions, redness or swelling
- An employee of the sponsor or the study site or members of their immediate family
- Any participant who, in the opinion of the Investigator, should not participate in the study.
Data sourced from ClinicalTrials.gov (NCT02928380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.