A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

A Randomized, Single-Blind Clinical Study Assessing the Maximum Maxillary Bite Force When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.

Study Overview

• Status: Completed
• Conditions: Denture Retention
• Intervention / Treatment: Device: Super Poligrip Free; Device: Experimental Denture Adhesive 1; Device: Experimental Denture Adhesive 2

Detailed Description

This will be a single-centre, controlled, randomized, single-blind (with respect to the examiner performing the incisal BF measurements), 4-treatment, 4- period, cross-over study to evaluate the maximum maxillary BF in a population of full maxillary denture wearers. A currently marketed denture adhesive will be used as a positive control, whilst use of no adhesive will be employed as a negative control.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Oral Health Research Institute Indiana University School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• A participant who is willing and able to comply with scheduled visits, and other study procedures.
• A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.

• A participant with a completely edentulous maxillary arch restored with a conventional maxillary full denture with an acrylic base. The maxillary denture prosthesis must fulfil all of the following:

  1. At least moderately well-fitting (Kapur Index, Olshan Modification: retention score Greater than or equal to (>=)2, stability score >=2) at the Screening (V1) visit,
  2. Is well made (according to the well-made assessment).

• A participant with BF measurements which satisfy all the following criteria:

  1. The qualifying BF measurements (without adhesive) at V1 (Screening) must be less than or equal to (=<) 9lbs.
  2. At least 2 of the 4 qualifying BF measurements (without adhesive) at V1 (Screening) must be reproducible (within +-2lbs).
  3. The Baseline BF measurement (without adhesive) at V2-5 must be <=9lbs.
  4. The Baseline BF measurement (without adhesive) at V2-5 and at least 1 of the 3 practice BF measurements must be within +-2lbs of each other.

• A participant who is dentate in the mandibular arch or has a partial or full denture in the mandibular arch that is:

  1. sufficiently stable, in the opinion of the investigator, to enable the bite force determination to be performed.
  2. well made (according to the well-made assessment).

Exclusion Criteria:

• A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family.
• A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to Visit 1 and/or during study participation.
• A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or experimental product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
• A participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• A participant unwilling or unable to comply with the Lifestyle Considerations.
• A participant who is currently taking or has taken a bisphosphonate drug (that is (i.e.), Fosamax, Actonel, Boniva).
• A participant who uses any medication or has a condition (e.g. insulin dependent diabetes) that, in the opinion of the investigator, would interfere with the conduct of the study.
• A participant who has any clinically significant or relevant oral abnormality (for example (e.g.) temporomandibular joint [TMJ] problems or tooth abnormalities) that, in the opinion of the investigator, could affect the BF measurements or participant safety.
• A participant who has any condition or medication which, in the opinion of the investigator, is currently causing xerostomia or which could interfere with the conduct of the study.
• A participant with a recent history (within the last year) of alcohol or other substance abuse.
• A participant with Oral soft tissue (OST) examination findings (at V1) such as stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling which in the opinion of the investigator, could interfere with the conduct of the study.
• A participant who has previously been enrolled in this study.
• A participant who is unable to comply with study requirements and/or who is not able to reliably perform a valid bite at the examiner's discretion.
• A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Negative Control; Denture adhesive will not be used.
Active Comparator: Positive Control; A single application of 1 gram of Super Poligrip Free denture adhesive will be applied topically to oral tissues via the upper denture.	Device: Super Poligrip Free; A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.
Experimental: Experimental Denture Adhesive 1; A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.	Device: Experimental Denture Adhesive 1; A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.
Experimental: Experimental Denture Adhesive 2; A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.	Device: Experimental Denture Adhesive 2; A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force	Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve [AUC]0-12) divided by 12 minus baseline BF (pounds [lbs]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).	Baseline and up to 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF	Natural logged incisal BF measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-t was defined as AUC 0-t divided by "t" minus baseline BF (lbs), where "t" is equal to 0.5, 1, 3, 6 and 9 hours. AUC was calculated from 0 to "t" hours using the trapezoid method; denoted as AUC 0-t. This transformation was carried out to return the measurement to the same scale as the original observation. AOB for 0.5, 1, 3, 6 and 9 hours were analyzed using the trapezoid method. AOB 0-0.5, AOB 0-1, AOB 0-3, AOB 0-6, AOB 0-9 were analyzed for each of the three treatments in comparison to no adhesive treatment group. Higher values of AOB demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).	Baseline, at 0.5, 1, 3, 6 and 9 hours

Collaborators and Investigators

• Sponsor: HALEON

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 218042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No