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

NCT05689814 | Completed

• 1 other identifier: 0708501
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dentures

Keywords

Denture Fixative

Outcome Measures

Primary Outcomes (1)

• Denture Retention Assessment at 1hour

  To assess denture retention of full maxillary arch after 1 hour with and without denture fixative using the Modified (Olshan) Kapur Index. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative.

  1 hour after denture fixative application or no fixative control

Secondary Outcomes (7)

• Denture Retention Assessment at 5minutes and 30minutes

  5mins and 30 mins after denture fixative application or no fixative control

• Denture Stability at 5minutes, 30minutes and 1hour

  5mins and 30 mins after denture fixative application or no fixative control

• Denture Hold Assessment

  ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours after denture fixative application or no fixative control

• Gum Comfort Assessment

  At the end of each participant's day during the 4-day treatment period for each arm

• Participant Satisfaction Assessment

  At the end of each participant's day during the 4-day treatment period for each arm

Study Arms (3)

Paraffin based Denture Fixative

EXPERIMENTAL

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.

Device: Paraffin based Denture Fixative

Polydecene based Denture Fixative

ACTIVE COMPARATOR

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.

Device: Paraffin based Denture Fixative

No Denture Fixative Control

NO INTERVENTION

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

Interventions

Paraffin based Denture Fixative DEVICE

Denture fixative applied in strips to secure dentures in place

Also known as: Denture Fixative

Paraffin based Denture Fixative; Polydecene based Denture Fixative

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential)
• 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

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• University of Leeds: collaborator

Study Sites (1)

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

Leeds, West Yorkshire, LS2 9LU, United Kingdom

Location

Study Officials

• Sue Pavitt, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking versus no fixative control will not be possible, however, clinical outcomes assessors will be masked to the two different investigational denture fixative products
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 19, 2023
• Study Start: January 30, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)