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

NCT ID: NCT05689814

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-09-01

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.

Conditions

Dentures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Paraffin based Denture Fixative

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.

Group Type: EXPERIMENTAL

Paraffin based Denture Fixative

Intervention Type: DEVICE

Denture fixative applied in strips to secure dentures in place

Polydecene based Denture Fixative

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.

Group Type: ACTIVE_COMPARATOR

Paraffin based Denture Fixative

Intervention Type: DEVICE

Denture fixative applied in strips to secure dentures in place

No Denture Fixative Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Paraffin based Denture Fixative

Denture fixative applied in strips to secure dentures in place

Intervention Type: DEVICE

Other Intervention Names

Denture Fixative

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leeds

OTHER

Sponsor Role: collaborator

Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sue Pavitt, Professor

Role: PRINCIPAL_INVESTIGATOR

Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, UK

Locations

Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

0708501

Identifier Type: -

Identifier Source: org_study_id