Last updated: 09/07/2020 10:40:11
A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Open-Label, Clinical Study to Evaluate a Methodology to Assess Food Occlusion Efficacy of a Denture Adhesive in Healthy, Edentulous Subjects
Trial description: The purpose of this study is to evaluate a methodology to determine the ability of a denture adhesive to restrict food ingress underneath dentures during eating.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Mass of peanuts under combined maxillary and mandibular dentures (denture adhesive applied per conventional pattern)
Timeframe: Upto 9 Weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
48
Primary completion date:
2017-15-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Denture Retention
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2017 to December 2017
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 85 Years
Accepts healthy volunteers
Yes
- Evidence of a personally 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.
- Male or female who, at the time of screening, are between the ages of 18 and 85 years, inclusive.
- An investigational site staff member directly involved in the conduct of the study or their family member, site staff members otherwise supervised by the investigator, or an employee of the sponsor directly involved in the conduct of the study.
- Participation in any other clinical study involving investigational drugs, cosmetics or
Inclusion and exclusion criteria
Inclusion criteria:
- Evidence of a personally 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.
- Male or female who, at the time of screening, are between the ages of 18 and 85 years, inclusive.
- Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Healthy, defined as in general good physical health, as judged by the investigator.
- Self-reports experience of getting food trapped under their denture.
- Is an habitual wearer of both of their dentures defined as participants who wear both of their dentures for the majority of their time whilst awake.
- Females of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 1 day after the last dose of assigned treatment.
- Female participants who are not of childbearing potential must meet following requirements: a) Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post-menopausal state, b) Have undergone a documented hysterectomy and/or bilateral oophorectomy, and have medically confirmed ovarian failure.
- Have denture prostheses that fulfil all of the following: a) A qualifying conventional acrylic full denture in both the upper and lower arch, b) Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6) (Olshan, 1992) with no individual stability or retention scores <1, c) Dentures are well made (according to the well-made assessment), and d) Has a peanut particle migration rating >0 for each denture.
Exclusion criteria:
- An investigational site staff member directly involved in the conduct of the study or their family member, site staff members otherwise supervised by the investigator, or an employee of the sponsor directly involved in the conduct of the study.
- Participation in any other clinical study involving investigational drugs, cosmetics or medical devices within 30 days prior to study entry and/or during study participation.
- Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Pregnant female participants.
- Breastfeeding female participants.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- History of swallowing difficulties or choking.
- Currently taking or have taken a bisphosphonate drug (i.e., Fosamax®, Actonel®, Boniva®) for treatment of osteoporosis.
- Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] problems) that, in the opinion of the investigator, could affect the participants participation in the study.
- Known allergy to peanuts or any other nut.
- Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
- Recent history (within the last year) of alcohol or other substance abuse.
- OST examination findings such as stomatitis, open sores, lesions, redness or swelling which in the opinion of the investigator, would interfere with the conduct of the study.
- Use of any medication that, in the opinion of the investigator, would interfere with the conduct of the study.
- A serious chronic disease requiring intermittent hospital visits.
- Having been previously enrolled in this study.
- 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
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
Study complete
Actual primary completion date
2017-15-12
Actual study completion date
2017-15-12
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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Access to clinical trial data by researchers
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