A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture Wearers

NCT03709810 | Completed Phase 4 Results FDA Device

• 1 other identifier: 209649
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the ability of a marketed denture adhesive to restrict food ingress underneath dentures during eating.

Conditions

Denture Retention

Outcome Measures

Primary Outcomes (1)

• Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures

  On each test day(Visit2,3)participants underwent an Oral Soft Tissue (OST) exam,dentures cleaned using denture cleanser.Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After60+/-5minutes(min) of replacing denture in the mouth,participants consumed 30-32g of non-salted peanuts, divided into smaller portions of approximately(app) 8nut halves. Each portion was chewed for app20 seconds(sec). After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed,any nuts remaining in mouth were collected using gauze.Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min,water was strained by sieve.Collected nuts washed,air-dried and transferred to pre-weighed aluminium weighing pans,dried at 40-degree Celsius (deg C)for 5 hours(h). Pans removed,cooled to room temperature,weighed to determine mass of nuts collected from each denture.

  Upto 16 days

Secondary Outcomes (4)

• Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture

  Upto 16 days

• Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture

  Upto 16 days

• Number of Denture Dislodgements During Chewing as Reported by Participants

  Upto 16 days

• Mean Scores From Participant Completed Questionnaire

  Upto 16 days

Study Arms (2)

Test Denture Adhesive

EXPERIMENTAL

Test denture adhesive will be applied directly from the tubes using a continuous strip pattern to the upper and lower denture which will then be placed in mouth of the participants.

Combination Product: Marketed Denture Adhesive (Super Poligrip Max Seal)

Control

OTHER

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

Other: No Adhesive

Interventions

Marketed Denture Adhesive (Super Poligrip Max Seal) COMBINATION_PRODUCT

The denture adhesive will be applied directly from the tubes. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.1 g for the maxillary and 0.6±0.1g for the mandibular dentures.

Test Denture Adhesive

No Adhesive OTHER

No adhesive will be applied.

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• 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.
• Participant is male or female who, at the time of screening, is between the ages of 18 and 85 years, inclusive.
• Participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
• Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/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.
• Self-reports experience of getting food trapped under their denture.
• Is a habitual wearer of both of their dentures defined as participants who wear both of their dentures for the majority of their time whilst awake.
• Have denture protheses that fulfil all of the following: a) A qualifying conventional acrylic full denture in both the upper and lower arch; b) Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6) with no individual stability or retention scores \<1; c) Dentures are well made (according to the well-made assessment); d) Has a peanut particle migration rating \>0 for each denture.

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 a pregnant female (self-reported).
• A Participant who is a breastfeeding female.
• 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 such as a) During the entire study Participants will not be permitted to have any dental/denture work performed during the time they are in the study, unless discussed and permitted by the examiner. This is to assure that the denture fit will not be altered during the study; b) During the treatment visits Participants will not be allowed to use tobacco or nicotine or nicotine-containing products following denture insertion until after their dentures are returned at completion of the food occlusion testing and Participants will not be allowed to use tobacco or nicotine or nicotine-containing products following denture insertion until after their dentures are returned at completion of the food occlusion testing.
• History of swallowing difficulties or choking.
• Currently taking or have taken a bisphosphonate drug (i.e., Fosamax, Actonel, Boniva).
• 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.
• Known allergy to peanuts or any other nut.
• Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
• Recent history (within the last year) of alcohol or other substance abuse.
• Oral soft tissue examination findings such as stomatitis, open sores, lesions, redness or swelling which in the opinion of the investigator, would interfere with the conduct of the study or the safety of the Participant.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

Related Links

• Related Info
• Related Info

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: phase 4
• 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 15, 2018
• First Posted: October 17, 2018
• Study Start: January 7, 2019
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: March 2, 2020
• Results First Posted: March 2, 2020

Record last verified: 2020-02

Locations

US (1)