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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Bite Force Study Assessing Two Currently Marketed Denture Adhesive Products Compared to No-Adhesive Control

Conditions
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Denture Retention

Intervention / Treatment
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* Other: Test Product
* Other: Positive Contol
* Other: Negative Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product<br>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. | Other: Test Product<br>* Five strips of test adhesive cream for upper denture, as per application instructions.<br>|
| Active Comparator: Positive Control<br>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. | Other: Positive Contol<br>* Three dabs of positive control adhesive cream for upper denture, as per application instructions.<br>|
| Other: Negative Control<br>Participants of this group will not be assigned to any treatment. | Other: Negative Control<br>* No adhesive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control) | 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 the Incisal Bite Force (Test Adhesive vs. Negative Control) | 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 |