Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress

Completed · Not applicable

Conditions studied: Denture Retention

In brief

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.

Key facts

Study ID

NCT02928380

Run by

GlaxoSmithKline

People needed

83

Starts

2016-07-25

Expected to finish

2016-09-16

Last updated by the study team

2018-08-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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