Clinical trial NCT05689814: Retention, Stability and Performance Assessment of Denture Fixatives Versus no Fixative Control
Official title: A Single-centre, Randomised, 3-way Cross-over, Clinical Investigation Comparing Denture Fixative Versus no Fixative Performance in Full Denture Wearers and an Exploratory Substudy in Partial Denture Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentures
Keywords: Denture Fixative
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
Collaborators: name: University of Leeds
First posted: 2023-01-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The denture fixative cream formulations will be tested in a 3-arm cross-over-design, where subjects will be randomised to a sequence including the two intervention (denture fixative) arms and a control (no fixative) arm.
Primary purpose: TREATMENT

Brief summary: This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control

Detailed description: A single-centre, randomised, 3-way cross-over, clinical investigation comparing the performance of two denture fixative versus no denture fixative control in full denture wearers and an exploratory sub study in partial denture wearers. The study will assess the performance and tolerance of two denture fixative cream formulations (Paraffin based and Polydecene based) when applied to full dentures.

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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)
3. Male or female participants aged between 18 and 85 years at the time of signing the informed consent form
4. Participants must have been using dentures daily for at least 6 months prior to the screening visit
5. Dentures must have been made in the last 5 years;
6. Dentures must be well-made based on design and construction in the opinion of the clinician
7. No clinically significant and relevant abnormalities in medical history or upon oral examination

Exclusion Criteria:

1. Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential)
2. 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)
3. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
4. 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
5. Participants with maxillofacial defects covered by prosthetics
6. Self-reported and/or visual manifestations of severe dry mouth (xerostomia) that may affect denture retention in the opinion of the Investigator
7. Participants with oral soft tissue examination findings such as stomatitis, open sores, ulcers, lesions, redness or swelling or associated lymphadenopathy

Primary outcomes:
measure: Denture Retention Assessment at 1hour
timeFrame: 1 hour after denture fixative application or no fixative control
Secondary outcomes:
measure: Denture Retention Assessment at 5minutes and 30minutes
timeFrame: 5mins and 30 mins after denture fixative application or no fixative control
measure: Denture Stability at 5minutes, 30minutes and 1hour
timeFrame: 5mins and 30 mins after denture fixative application or no fixative control
measure: Denture Hold Assessment
timeFrame: ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours after denture fixative application or no fixative control
measure: Gum Comfort Assessment
timeFrame: At the end of each participant's day during the 4-day treatment period for each arm
measure: Participant Satisfaction Assessment
timeFrame: At the end of each participant's day during the 4-day treatment period for each arm
measure: Oral Health Assessment
timeFrame: To be completed once during the participant's clinic visit on days 2,3,4,5,6,7 and 8 comparing with and without fixative
measure: Bite Force Assessment
timeFrame: To be completed once during the participant's clinic visit on days 3, 5 and 7
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds
state: West Yorkshire
Study officials:
affiliation: Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, UK
name: Sue Pavitt, Professor
role: PRINCIPAL_INVESTIGATOR
References: