A Clinical Study to Assess Force Required to Dislodge Upper Denture With and Without Use of a Novel Denture Adhesive

NCT04473521 | Withdrawn Phase 3

• 1 other identifier: 213629
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the hold properties of an investigational denture adhesive using an established methodology called the maximum incisal bite force (BF), and Kapur-Olshan (KO) index for denture retention and stability. The effects of hot drinks and two questionnaires relating to participants' perception will also be assessed for the investigational denture adhesive.

Conditions

Denture Retention

Outcome Measures

Primary Outcomes (1)

• Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force (BF)

  Incisal bite force measurements will be performed to analyse the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements will be conducted by an examiner. AOB0-12 will be used to assess the incisal bf and is defined as (AUC0-12)/12 minus baseline BF(pounds \[lbs\]). Area under the Curve (AUC) is calculated from 0 to 12 hours (hr) using the trapezoid method; denoted as AUC0-12. This transformation will return the measurement to the same scale as the original observations. Area over baseline in BF as measured by AOB0-12 will be analyzed for each of the three interventional products, compared to no adhesive. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.

  Up to 12 hours

Secondary Outcomes (12)

• Area Over Baseline (AOB) at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal Bite Force

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

• Kapur Olshan (KO) Index Scores for Denture Retention

  Baseline, at 3 hours

• Kapur Olshan (KO) Index Scores for Denture Stability

  Baseline, at 3 hours

• Composite Kapur Olshan (KO) Index Scores for Denture Retention and Stability

  Baseline, at 3 hours

• Area Over Baseline (AOB) at 0.5, 1, 3, 6, 9 and 12 Hours to Compare Maximum Incisal Bite Force Following the Consumption of a Hot Drink

  Baseline, at 0.5, 1, 3, 6, 9 and 12 hours

Study Arms (4)

No Adhesive

NO INTERVENTION

No adhesive will be applied.

Super Poligrip Free (SPF)

ACTIVE COMPARATOR

The denture adhesive of 1.00grams (g) +/- 0.05g will be applied to only the maxillary denture in long, continuous strips manner that is controlled by weight for the maxillary dentures. Mandibular denture will be stabilised using this adhesive up to 2 times (maximum \[max\] 3 adhesive applications per day) at examiner's discretion.

Device: Super Poligrip Free

Investigational Adhesive

EXPERIMENTAL

The denture adhesive of 1.00g +/- 0.05g will be applied only to the maxillary denture only in long, continuous strips manner that is controlled by weight for the maxillary dentures. Mandibular denture will be stabilized using SPF adhesive up to 2 times (max 3 adhesive applications per day) at examiner's discretion.

Device: Investigational denture adhesive cream

Investigational Adhesive + Hot drink

EXPERIMENTAL

The denture adhesive of 1.00g +/- 0.05g will be applied to only the maxillary denture in long, continuous strips manner that is controlled by weight for the maxillary dentures. Hot drinks will be provided within 1 hour of completing lunch and dinner and must be consumed within 30 minutes. Mandibular denture will be stabilized using SPF adhesive up to 2 times (max 3 adhesive applications per day) at examiner's discretion.

Device: Investigational denture adhesive cream

Interventions

Investigational denture adhesive cream DEVICE

The denture adhesive application will be controlled by weight (1.00g +/-0.05g) applied to the maxillary denture only.

Investigational Adhesive; Investigational Adhesive + Hot drink

Super Poligrip Free DEVICE

The denture adhesive application will be controlled by weight (1.00g +/- 0.05g) applied to the maxillary denture only.

Super Poligrip Free (SPF)

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.
• 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,
• Are well made (according to the well-made assessment).
• Participant with BF measurements which satisfy the following criteria:
• The "qualifying" BF measurements (without adhesive) at V1 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 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 study entry 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 investigational 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 who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
• A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
• A participant who is currently taking or has taken a bisphosphonate drug (i.e., Fosamax, Actonel, Boniva).
• Use of any medication or 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 (e.g. temporomandibular joint \[TMJ\] problems) that, in the opinion of the investigator, could affect the participant's participation in the study.
• A participant clinically identified as having an incisal bite relation or any other tooth abnormality which 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 would 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 OST examination findings (at V1) such as stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling which in the opinion of the investigator, would interfere with the conduct of the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 16, 2020
• Study Start: October 4, 2020
• Primary Completion: January 10, 2021
• Study Completion: January 10, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01

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 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)