Last updated: 07/11/2019 04:10:52
Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study to Evaluate the Ability of an Experimental Denture Adhesive to Prevent Food Particle Ingress Under Dentures
Trial description: 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.
Primary purpose:
Supportive Care
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Combined mass of peanuts (gram) (from upper and lower dentures) for reference denture adhesive and on no adhesive use
Timeframe: Up to 17 days
Secondary outcomes:
Combined mass of peanuts (gram) (from upper and lower dentures) for an experimental denture adhesive and on no adhesive use
Timeframe: Up to 17 days
Combined mass of peanuts (gram) (from upper and lower dentures) for an experimental denture adhesive and reference denture adhesive
Timeframe: up to 17 days
Composite kapur (olshan modification) index scores for denture retention and stability
Timeframe: Up to 17 days
Kapur (olshan modification) index scores for denture retention
Timeframe: Up to 17 days
Kapur (olshan modification) index scores for denture stability
Timeframe: Up to 17 days
Interventions:
Device: Experimental Denture Adhesive
Device: Reference (Marketed) Denture Adhesive
Enrollment:
83
Observational study model:
Not applicable
Primary completion date:
2016-16-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Denture Retention
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2016 to September 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 85 years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-16-09
Actual study completion date
2016-16-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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