A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive

NCT02937870 | Completed Results FDA Device

• 1 other identifier: 206233
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite force study will be to compare bite force measurements over a 12 hour period across two (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control.

Conditions

Denture Retention

Outcome Measures

Primary Outcomes (2)

• Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive

  Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (pounds \[lbs\]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.

  up to 12 hours

• Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive

  Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.

  up to 12 hours

Secondary Outcomes (3)

• Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive

  up to 12 hours

• Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive

  up to 12 hours

• Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2

  up to 12 hours

Study Arms (4)

Test Product 1

EXPERIMENTAL

Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.

Device: Test Product 1

Test Product 2

EXPERIMENTAL

Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.

Device: Test Product 2

Reference Product

ACTIVE COMPARATOR

Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.

Device: Reference Product

Negative Control

OTHER

Other: Negative Control

Interventions

Test Product 1 DEVICE

Test adhesive 1 with a thin nozzle

Test Product 1

Test Product 2 DEVICE

Test adhesive 2 with a thin nozzle

Test Product 2

Reference Product DEVICE

Adhesive Cream

Reference Product

Negative Control OTHER

No adhesive

Negative Control

Eligibility Criteria

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

You may qualify if:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Aged between 18 to 85 years.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination and absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
• Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture. Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. Maxillary dentures must be considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan Modification: retention score \>=2, stability score \>=2). Maxillary dentures and mandibular dentures, if present, must be considered to be well-made based on design and construction criteria specified in the protocol. The qualifying maxillary incisal bite force readings (without adhesive) must be less than or equal to 9 pounds (lb) at the Screening Visit and subsequent visit pre-treatment baseline bites. At least 2 of the 4 qualifying bite readings at the Screening Visit must be reproducible (+/- 2lb). At subsequent visits the bite force readings must be within +/-2lb for 1 of the 3 practice bites and the pre-treatment baseline bite.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.

You may not qualify if:

• A woman who is known to be pregnant or who is intending to become pregnant (self reported) over the duration of the study.
• A woman who is breast-feeding.
• Implanted with a cardiac pacemaker.
• Daily doses of medication that might interfere with the ability to perform the study according to protocol (as determined by the Investigator).
• Taking or have taken a bisphosphonate drug for treatment of osteoporosis.
• A serious chronic disease requiring hospitalization.
• Any condition not previously mentioned that in the Investigator's opinion may impair the study evaluation.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• 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.
• Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements.
• Severe dry mouth that may affect denture retention in the opinion of the Investigator.
• OST examination findings such as stomatitis, open sores, lesions, redness or swelling that, in the opinion of the investigator, could affect the participant's participation in the study.
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
• Previous participation in this study.
• Recent history (within the last year) of alcohol or other substance abuse.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bloomfield, New Jersey, 07003, United States

Location

Related Publications (1)

• Atassi M, Ling MR, Oneglia K, Dilauro TS. A proof-of-principle bite force study using two experimental test denture adhesives and a currently marketed denture adhesive. Clin Exp Dent Res. 2020 Apr;6(2):266-273. doi: 10.1002/cre2.256. Epub 2020 Feb 6.

  PMID: 32026625 DERIVED

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: October 17, 2016
• First Posted: October 19, 2016
• Study Start: March 7, 2017
• Primary Completion: April 5, 2017
• Study Completion: April 5, 2017
• Last Updated: May 23, 2018
• Results First Posted: March 26, 2018

Record last verified: 2018-02

Locations

US (1)