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

Dentures Clinical Trial

— RESONATE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05689814
• Other study ID #: 0708501
• Status: Completed
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2024
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentures

Intervention

Device:
• Paraffin based Denture Fixative
Denture fixative applied in strips to secure dentures in place

Locations

Country	Name	City	State
United Kingdom	Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited	University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Denture Retention Assessment at 5minutes and 30minutes	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.	5mins and 30 mins after denture fixative application or no fixative control
Secondary	Denture Stability at 5minutes, 30minutes and 1hour	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.	5mins and 30 mins after denture fixative application or no fixative control
Secondary	Denture Hold Assessment	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	=2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours after denture fixative application or no fixative control
Secondary	Gum Comfort Assessment	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)	At the end of each participant's day during the 4-day treatment period for each arm
Secondary	Participant Satisfaction Assessment	To assess participant satisfaction of the denture fixatives using the Modified (Kulak) Kelsey questionnaire compared to no fixative control	At the end of each participant's day during the 4-day treatment period for each arm
Secondary	Oral Health Assessment	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.	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
Secondary	Bite Force Assessment	To measure Bite force by means of a digital gnathometer to compare the denture fixatives to no fixative control	To be completed once during the participant's clinic visit on days 3, 5 and 7