Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress

NCT02928380 | Completed Results

• 1 other identifier: 205915
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive.

Conditions

Denture Retention

Outcome Measures

Primary Outcomes (1)

• Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use

  Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).

  Up to 17 days

Secondary Outcomes (5)

• Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use

  Up to 17 days

• Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive

  up to 17 days

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

  Up to 17 days

• Kapur (Olshan Modification) Index Scores for Denture Retention

  Up to 17 days

• Kapur (Olshan Modification) Index Scores for Denture Stability

  Up to 17 days

Study Arms (3)

Reference Denture Adhesive

ACTIVE COMPARATOR

Participants applied reference denture adhesive as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.

Device: Reference (Marketed) Denture Adhesive

Test Denture Adhesive

EXPERIMENTAL

Participants applied test denture adhesive as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.

Device: Experimental Denture Adhesive

No Adhesive (Negative Control)

NO INTERVENTION

Participants did not apply any denture adhesive in this treatment arm.

Interventions

Experimental Denture Adhesive DEVICE

Participants received a single application of test denture adhesive with a Flat Ribbon Nozzle as 3 Continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture which were placed in the mouth.

Test Denture Adhesive

Reference (Marketed) Denture Adhesive DEVICE

Participants received a single application of marketed denture adhesive with a flat ribbon nozzle as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture, which were placed in the mouth.

Reference Denture Adhesive

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 and 85 years inclusive
• Understands and is willing, able and likely to comply with all study procedures and restrictions
• Good general and mental health with, in the opinion of the investigator or medically qualified designee:No clinically significant and relevant abnormalities of medical or physical history; Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures
• A qualifying full denture in both the upper and lower arch
• Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6)
• Dentures are well made (according to the well-made assessment)
• Participants must report that they get food trapped under their denture
• A peanut particle migration rating \>0 for both dentures at screening

You may not qualify if:

• Women who are known to be pregnant (participant-reported) or who are intending to become pregnant over the duration of the study
• Women who are breast-feeding
• Medications, which in the opinion of the investigator, would interfere with the conduct of the study
• Taking or have taken a bisphosphonate drug for treatment of osteoporosis
• A serious chronic disease requiring hospitalization
• History of swallowing difficulties or choking
• Any condition not previously mentioned that in the investigator's opinion may impair the study evaluation
• Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Known allergy to peanuts or any other nut
• 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
• OST examination findings such as stomatitis, open sores, lesions, redness or swelling
• An employee of the sponsor or the study site or members of their immediate family

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

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: July 18, 2016
• First Posted: October 10, 2016
• Study Start: July 25, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 16, 2016
• Last Updated: August 27, 2018
• Results First Posted: December 6, 2017

Record last verified: 2018-07

Locations

US (1)