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

Not Applicable

Completed

• Conditions: Dentures
• Interventions: Device: Paraffin based Denture Fixative

• Registration Number: NCT05689814
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

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.

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Study Start: 2023-01-30
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Paraffin based Denture Fixative	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.
Polydecene based Denture Fixative	Paraffin 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.

Primary Outcome Measures

Name	Time	Method
Denture Retention Assessment at 1hour	1 hour after denture fixative application or no fixative control	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.

Secondary Outcome Measures

Name	Time	Method
Denture Retention Assessment at 5minutes and 30minutes	5mins and 30 mins after denture fixative application or no fixative control	To assess denture retention in full maxillary arch (and mandibular arch in fully edentulous participants) using the Modified (Olshan) Kapur Index at 5 and 30 minutes. 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.
Denture Stability at 5minutes, 30minutes and 1hour	5mins and 30 mins after denture fixative application or no fixative control	To assess denture stability in full mandibular arch (if present) using the Modified (Olshan) Kapur Index as separate scores at 5minutes, 30 minutes and 1 hour.
Gum Comfort Assessment	At the end of each participant's day during the 4-day treatment period for each arm	To assess gum comfort using the Gum Comfort questionnaire comparing denture fixative to no fixative control over periods of 4 days (change in overall mean score and individual responses)
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	To assess denture hold (retention and stability) at ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours using the Modified (Kulak) Kelsey questionnaire compared to no fixative control
Participant Satisfaction Assessment	At the end of each participant's day during the 4-day treatment period for each arm	To assess participant satisfaction of the denture fixatives using the Modified (Kulak) Kelsey questionnaire compared to no fixative control
Bite Force Assessment	To be completed once during the participant's clinic visit on days 3, 5 and 7	To measure Bite force by means of a digital gnathometer to compare the denture fixatives to no fixative control
Oral Health Assessment	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	To make a clinical assessment of the oral health impact profile of participants using the Oral Health Impact Profile-Edentulous (OHIP-EDENT) questionnaires after 4 days use of each of the dental fixatives administered and no fixative control.

Trial Locations

Locations (1)

Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds; 🇬🇧 Leeds, West Yorkshire, United Kingdom