Last updated: 02/28/2020 16:00:12
A Study to investigate food occlusion efficacy of a denture adhesive in denture wearers
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Single-Blind, Clinical Study to Assess Food Occlusion Efficacy of a Marketed Denture Adhesive in Healthy, Edentulous Subjects
Trial description: The purpose of this study is to determine the ability of a marketed denture adhesive to restrict food ingress underneath dentures during eating.
Primary purpose:
Supportive Care
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mass of peanuts under combined maxillary and mandibular dentures
Timeframe: After 1 hour.
Secondary outcomes:
Mass of peanuts under maxillary denture
Timeframe: After 1 hour
Mass of peanuts under mandibular denture
Timeframe: After 1 hour
Mean scores from participant-completed questionnaire
Timeframe: After 1 hour
Interventions:
Enrollment:
49
Primary completion date:
2019-24-01
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)
January 2019 to January 2019
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 85 years
Accepts healthy volunteers
No
- Participant provision of a 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.
- Participant is male or female who, at the time of screening, is between the ages of 18 and 85 years, inclusive.
- A Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- A Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant provision of a 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.
- Participant is male or female who, at the time of screening, is between the ages of 18 and 85 years, inclusive.
- Participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
- Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history or upon oral examination, or condition, that would impact the Participant’s safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual’s ability to understand and follow study procedures and requirements.
- Self-reports experience of getting food trapped under their denture.
- Is a habitual wearer of both of their dentures defined as participants who wear both of their dentures for the majority of their time whilst awake.
- Have denture protheses 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) with no individual stability or retention scores <1; c) Dentures are well made (according to the well-made assessment); d) Has a peanut particle migration rating >0 for each denture.
Exclusion criteria:
- A Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- A Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A Participant with, in the opinion of the investigator or medically qualified designee, an 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 or medically qualified designee, would make the Participant inappropriate for entry into this study.
- A Participant who is a pregnant female (self-reported).
- A Participant who is a breastfeeding female.
- A Participant with known or suspected intolerance or hypersensitivity to the study materials(or closely related compounds) or any of their stated ingredients.
- A Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
- A Participant unwilling or unable to comply with the Lifestyle Considerations such as a) During the entire study Participants will not be permitted to have any dental/denture work performed during the time they are in the study, unless discussed and permitted by the examiner. This is to assure that the denture fit will not be altered during the study; b) During the treatment visits Participants will not be allowed to use tobacco or nicotine or nicotine-containing products following denture insertion until after their dentures are returned at completion of the food occlusion testing and Participants will not be allowed to use tobacco or nicotine or nicotine-containing products following denture insertion until after their dentures are returned at completion of the food occlusion testing.
- History of swallowing difficulties or choking.
- Currently taking or have taken a bisphosphonate drug (i.e., Fosamax, Actonel, Boniva).
- Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] problems) that, in the opinion of the investigator, could affect the Participant’s 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.
- Oral soft tissue 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 or the safety of the Participant.
- 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, in the opinion of the investigator, who 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
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
2019-24-01
Actual study completion date
2019-24-01
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
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