- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02928380
Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress
July 26, 2018 updated by: GlaxoSmithKline
A Clinical Study to Evaluate the Ability of an Experimental Denture Adhesive to Prevent Food Particle Ingress Under Dentures
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46825
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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.
|
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.
|
EXPERIMENTAL: 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.
|
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_INTERVENTION: No Adhesive (Negative Control)
Participants did not apply any denture adhesive in this treatment arm.
|
What is the study measuring?
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
Time Frame: Up to 17 days
|
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
Time Frame: Up to 17 days
|
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
Time Frame: up to 17 days
|
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
Time Frame: Up to 17 days
|
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
Time Frame: Up to 17 days
|
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
Time Frame: Up to 17 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 25, 2016
Primary Completion (ACTUAL)
September 1, 2016
Study Completion (ACTUAL)
September 16, 2016
Study Registration Dates
First Submitted
July 18, 2016
First Submitted That Met QC Criteria
October 6, 2016
First Posted (ESTIMATE)
October 10, 2016
Study Record Updates
Last Update Posted (ACTUAL)
August 27, 2018
Last Update Submitted That Met QC Criteria
July 26, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 205915
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Denture Retention
-
GlaxoSmithKlineWithdrawnDenture RetentionUnited States
-
GlaxoSmithKlineCompletedDenture RetentionUnited States
-
HALEONCompleted
-
GlaxoSmithKlineCompletedDenture RetentionUnited States
-
Cairo UniversityCompletedDenture Retention | Complete DenturesEgypt
-
GlaxoSmithKlineCompletedDenture RetentionUnited States
-
GlaxoSmithKlineCompletedDenture RetentionUnited States
-
GlaxoSmithKlineCompletedDenture RetentionCanada
-
Heidelberg UniversityUnknownOral Health | Tooth Abrasion | Denture, Partial, Removable | Dental Prosthesis RetentionGermany
-
The University of Hong KongCompletedDenture | Cetylpyridinium Chloride | Removable Partial Denture | Denture Cleansers
Clinical Trials on Reference (Marketed) Denture Adhesive
-
GlaxoSmithKlineCompletedDenture RetentionUnited States
-
Procter and GambleCompleted
-
GlaxoSmithKlineCompletedDenture RetentionUnited States
-
Johnson & Johnson Consumer Inc. (J&JCI)CompletedWound HealingUnited States
-
HALEONCompleted
-
GlaxoSmithKlineCompletedDenture RetentionCanada
-
The University of Hong KongRecruiting
-
University of JordanCompleted
-
Chulalongkorn UniversityCompletedComplete Edentulism | Complete DentureThailand
-
Chattem, Inc.CompletedTolerability | Adhesiveness | Dermal Irritation | Effects of HeatUnited States