A Clinical Bite Force Study of Two Marketed Adhesives Against no Adhesive

NCT ID: NCT03037307

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2017-05-04

Brief Summary

The objective of this study will be to compare bite force (BF) measurements over a 12-hour period of a currently marketed denture adhesive cream based on carbomer technology (test), with a positive control and a negative/no treatment control.

Detailed Description

This will be a single centre, randomized, crossover, 3-treatment, 3-period study to compare BF measurements over a 12 hour period of a currently marketed denture adhesive cream based on carbomer technology (test), with a positive control, and a negative/no treatment control. A short questionnaire regarding the flavor and texture characteristics of each denture adhesive after a single use will also be used to generate data for these attributes. This study included four visits: Visit 1 (screening visit), Visit 2, 3, 4 (treatment visits).

Conditions

Denture Retention

Study Design

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

Study Groups

Test product

Participants will topically apply the test product to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.

Group Type: EXPERIMENTAL

Test Product

Intervention Type: OTHER

Five strips of test adhesive cream for upper denture, as per application instructions.

Positive Control

Participants will topically apply the positive control to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.

Group Type: ACTIVE_COMPARATOR

Positive Contol

Intervention Type: OTHER

Three dabs of positive control adhesive cream for upper denture, as per application instructions.

Negative Control

Participants of this group will not be assigned to any treatment.

Group Type: OTHER

Negative Control

Intervention Type: OTHER

No adhesive

Interventions

Test Product

Five strips of test adhesive cream for upper denture, as per application instructions.

Intervention Type: OTHER

Positive Contol

Three dabs of positive control adhesive cream for upper denture, as per application instructions.

Intervention Type: OTHER

Negative Control

No adhesive

Intervention Type: OTHER

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 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; absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
• Diagnosis: a) Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture, b) Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture, c) Maxillary dentures must be considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan Modification: retention score >2, stability score >2) d) Maxillary dentures and mandibular dentures, if present, must be considered to be well-made based on design and construction criteria specified in the protocol e) The qualifying maxillary incisal BF readings (without adhesive) must be less than or equal to 9 pounds at the Screening Visit and subsequent visit pretreatment baseline bites. f) 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.

Exclusion Criteria

• 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.
• a) Implanted with a cardiac pacemaker, b) Daily doses of medication that might interfere with the ability to perform the study according to protocol (as determined by the Investigator), c) Insulin dependent diabetics, d) Taking or have taken a bisphosphonate drug for treatment of osteoporosis, e) A serious chronic disease requiring hospitalization, f) 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.
• a) 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, b) Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements, c) Severe dry mouth that may affect denture retention in the opinion of the Investigator, d) 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. e) A serious chronic disease requiring hospitalization. f) 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.
• a) 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, b) Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements, c) Severe dry mouth that may affect denture retention in the opinion of the Investigator, d) 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.
• a) Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit, b) Previous participation in this study.
• Recent history (within the last year) of alcohol or other substance abuse.
• A participant who is unwilling to refrain from smoking, including e-cigarettes and the use of chewing tobacco or other tobacco products for the duration of screening and each treatment day (12-14 hours).
• An employee of the sponsor or the study site or members of their immediate family.

• 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

Indianapolis, Indiana, United States

Countries

United States

References

Varghese R, Burnett GR, Souverain A, Patil A, Gossweiler AG. A randomised bite force study assessing two currently marketed denture adhesive products compared with no-adhesive control. Clin Exp Dent Res. 2019 May 14;5(3):276-283. doi: 10.1002/cre2.182. eCollection 2019 Jun.

Reference Type: DERIVED

PMID: 31249709 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

207545

Identifier Type: -

Identifier Source: org_study_id