Retention, Stability and Performance Assessment of Denture Fixatives Versus no Fixative Control (RESONATE)

Reckitt Benckiser

Status: Completed

Conditions: Dentures

Treatments: Device: Paraffin based Denture Fixative

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05689814

0708501

Details and patient eligibility

About

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

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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71 participants in 3 patient groups

Paraffin based Denture Fixative

Experimental group

Description:

Participants will use the paraffin-based denture fixative to secure their denture for 4 days and an additional 21-35 days during the observational (safety) period in accordance with the randomization schedule.

Treatment:

Device: Paraffin based Denture Fixative

Polydecene based Denture Fixative

Active Comparator group

Description:

Participants will use the polydecene based denture fixative to secure their denture for 4 days and an additional 21-35 days during the observational (safety) period in accordance with the randomization schedule.

Treatment:

Device: Paraffin based Denture Fixative

No Denture Fixative Control

No Intervention group

Description:

Participants will continue to wear their dentures for 4 days and will not use any denture fixative as part of this study arm.