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

NCT05173974 | Completed Phase 3 Results FDA Device

• 1 other identifier: 218042
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Denture Retention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF

  Baseline, at 0.5, 1, 3, 6 and 9 hours

Study Arms (4)

Negative Control

NO INTERVENTION

Denture adhesive will not be used.

Positive Control

ACTIVE COMPARATOR

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

Experimental Denture Adhesive 1

EXPERIMENTAL

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

Experimental Denture Adhesive 2

EXPERIMENTAL

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

Interventions

Super Poligrip Free DEVICE

A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.

Positive Control

Experimental Denture Adhesive 1 DEVICE

A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.

Experimental Denture Adhesive 1

Experimental Denture Adhesive 2 DEVICE

A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.

Experimental Denture Adhesive 2

Eligibility Criteria

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

You may qualify if:

• 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:
• 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,
• Is well made (according to the well-made assessment).
• A participant with BF measurements which satisfy all the following criteria:
• The qualifying BF measurements (without adhesive) at V1 (Screening) must be less than or equal to (=\<) 9lbs.
• At least 2 of the 4 qualifying BF measurements (without adhesive) at V1 (Screening) must be reproducible (within +-2lbs).
• The Baseline BF measurement (without adhesive) at V2-5 must be \<=9lbs.
• 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:
• sufficiently stable, in the opinion of the investigator, to enable the bite force determination to be performed.
• well made (according to the well-made assessment).

You may not qualify if:

• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Oral Health Research Institute Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+447880182593

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: December 30, 2021
• Study Start: February 8, 2022
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (1)