Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Study to Evaluate the Ability of an Experimental Denture Adhesive to Prevent Food Particle Ingress Under Dentures

Conditions
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Denture Retention

Intervention / Treatment
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* Device: Experimental Denture Adhesive
* Device: Reference (Marketed) Denture Adhesive


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 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.

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference Denture Adhesive<br>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<br>* 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.<br>|
| Experimental: Test Denture Adhesive<br>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<br>* 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.<br>|
| No Intervention: No Adhesive (Negative Control)<br>Participants did not apply any denture adhesive in this treatment arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental 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 | 
| Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive | 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 | 
| Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability | Kapur (Olshan modification) Index score was assessed to examine each denture (upper & lower) for retention & stability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull & lateral force: 5=Excellent;4=Very Good;3=Good;2=Fair;1= Poor;0=No retention. Stability was measured as score of 0-4 to assess nature of rocking offered by denture base on its supporting structures under pressure:4=Excellent (no rocking);3=Good (very slight rocking);2=Fair (slight rocking);1=Poor (moderate rocking);0=No stability (extreme rocking). Composite Kapur (Olshan modification) Index scores was measured as the sum score of retention & stability for upper or lower dentures separately such that a sum score of zero represents no retention and stability and a sum score of 9 represents excellent retention and stability. | Up to 17 days | 
| Kapur (Olshan Modification) Index Scores for Denture Retention | Kapur (Olshan modification) Index scores were assessed to examine each denture (upper & lower) for its retention ability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull & lateral force: 5=Excellent - denture offered excellent resistance to vertical pull and lateral force; 4= Very Good- denture offered very good resistance to vertical pull and lateral force; 3= Good- denture offered moderate resistance to vertical pull and lateral force; 2= Fair- denture offered moderate resistance to vertical pull and little or no resistance to lateral forces; 1= Poor- denture offers slight resistance to vertical pull and little or no resistance to lateral force; 0= No retention- when the denture was seated in place, it displaced itself. Higher the score, higher the retention ability of denture. | Up to 17 days | 
| Kapur (Olshan Modification) Index Scores for Denture Stability | Kapur (Olshan modification) Index scores were assessed to examine each denture (upper & lower) for its stability ability. Stability was measured using score of 0-4: 4= Excellent- when denture base offered no rocking on its supporting structures under pressure; 3= Good- when denture base had very slight rocking on its supporting structures under pressure; 2= Fair- when denture base had slight rocking on its supporting structures under pressure; 1= Poor- when denture base had moderate rocking on its supporting structures under pressure; 0= No stability- when denture base had extreme rocking under pressure. Higher the score, higher the stability ability of denture. | Up to 17 days |