Retention, Stability and Performance Assessment of Denture Fixatives Versus no Fixative Control (NCT05689814) | Clinical Trial Compass
CompletedNot Applicable
Retention, Stability and Performance Assessment of Denture Fixatives Versus no Fixative Control
United Kingdom71 participantsStarted 2023-01-30
Plain-language summary
This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants with a completely edentulous maxillary \[UPPER\] arch restored with a conventional full acrylic-based complete denture and dentate, partial, or full edentulous mandibular \[LOWER\], which may be restored with a stable complete, partial or implant supported denture
. For complete denture wearers, maxillary \[UPPER\] dentures must be completely removable standard acrylic dentures, which are at least moderately well-fitting at the screening visit (modified (Olshan) Kapur Index: retention score ≥2, stability score ≥2)
. Male or female participants aged between 18 and 85 years at the time of signing the informed consent form
. Participants must have been using dentures daily for at least 6 months prior to the screening visit
. Dentures must have been made in the last 5 years;
. Dentures must be well-made based on design and construction in the opinion of the clinician
. No clinically significant and relevant abnormalities in medical history or upon oral examination
Exclusion criteria
. Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Denture Retention Assessment at 1hour
Timeframe: 1 hour after denture fixative application or no fixative control
. Daily doses of medication that might interfere with the ability to perform the study according to protocol or affect study assessments, for example, bisphosphonates (oral or intravenous) (as determined by the Investigator)
. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
. Any clinically significant or relevant oral abnormality (e.g., temporomandibular joint \[TMJ\] problems), or recent (within last 6 months) oral surgery / intervention, or oral health concern that, in the opinion of the investigator, could affect the participant's participation in the study
. Participants with maxillofacial defects covered by prosthetics
. Self-reported and/or visual manifestations of severe dry mouth (xerostomia) that may affect denture retention in the opinion of the Investigator
. Participants with oral soft tissue examination findings such as stomatitis, open sores, ulcers, lesions, redness or swelling or associated lymphadenopathy