Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress

NCT ID: NCT02928380

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-25
• Study Completion Date: 2016-09-16

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.

Detailed Description

The aim of this study is to explore the mass of food particle ingress when an adhesive is extruded through the new nozzle with directed application compared to the use of no adhesive and a marketed adhesive (extruded through a flat ribbon nozzle [FRN]) with standard application as per product label, utilizing a peanut occlusion methodology. This was a single center, controlled, single blind (to the examiner performing the safety assessments (oral soft tissue [OST] examination) and the laboratory staff weighing the peanut particles), randomized, three-treatment, three-period, cross-over design in participants with full upper and lower dentures. Each treatment period consisted of one day of testing with at least two days between treatment visits. This study consisted four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit.

Conditions

Denture Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Reference Denture Adhesive

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.

Group Type: ACTIVE_COMPARATOR

Reference (Marketed) Denture Adhesive

Intervention Type: 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.

Test Denture Adhesive

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.

Group Type: EXPERIMENTAL

Experimental Denture Adhesive

Intervention Type: 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.

No Adhesive (Negative Control)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental Denture Adhesive

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.

Intervention Type: DEVICE

Reference (Marketed) Denture Adhesive

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Any participant who, in the opinion of the Investigator, should not participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

205915

Identifier Type: -

Identifier Source: org_study_id