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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Denture Adhesive | Active Comparator | 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. |
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| Test Denture Adhesive | Experimental | 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. |
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| No Adhesive (Negative Control) | No Intervention | Participants did not apply any denture adhesive in this treatment arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Denture Adhesive | Device | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fort Wayne | Indiana | 46825 | United States |
A total of 91 participants were screened, out of which only 83 participants were randomized to the study. 8 participants were not randomized: 7 participants due to screening failure and 1 participant due lost to follow up.
Participants were recruited at a single center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference Denture Adhesive/Test Denture Adhesive/No Adhesive | Participants received reference denture adhesive, test denture adhesive and no adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days. |
| FG001 | Reference Denture Adhesive/No Adhesive/Test Denture Adhesive | Participants received reference denture adhesive, no adhesive and test denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days. |
| FG002 | Test Denture Adhesive/Reference Denture Adhesive/No Adhesive | Participants received test denture adhesive, reference denture adhesive and no adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days. |
| FG003 | Test Denture Adhesive/No Adhesive/Reference Denture Adhesive | Participants received test denture adhesive, no adhesive and reference denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days. |
| FG004 | No Adhesive/Reference Denture Adhesive/Test Denture Adhesive | Participants received no adhesive, reference denture adhesive and test denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days. |
| FG005 | No Adhesive/Test Denture Adhesive/Reference Denture Adhesive | Participants received no adhesive, test denture adhesive and reference denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
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| Period 1 |
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| Wash Out Period 1 |
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Baseline analysis was performed on Intention to treat (ITT) population which included all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | All the participants received all three treatments (reference denture adhesive, test denture adhesive and no adhesive) in the study period 1, 2, and 3 according to the randomization sequence. Each treatment period was separated by washout period of 2-7 days. All randomized participants were included for baseline evaluation. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment. | Posted | Mean | Standard Deviation | gram (g) | Up to 17 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Denture Adhesive | Participants received reference denture adhesive by site staff 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Reference (Marketed) Denture Adhesive | Device | 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. |
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| 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 |
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| COMPLETED |
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| COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG000 |
| Reference Denture Adhesive |
Participants received reference denture adhesive by site staff 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. |
| OG001 | No Adhesive (Negative Control) | Participants did not receive any denture adhesive by site staff in this treatment arm. |
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| Secondary | 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). | Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment. | Posted | Mean | Standard Deviation | g | Up to 17 days |
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| Secondary | 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). | Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment. | Posted | Mean | Standard Deviation | g | up to 17 days |
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| Secondary | 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. | Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | Up to 17 days |
|
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| Secondary | 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. | Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | Up to 17 days |
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| Secondary | 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. | Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | Up to 17 days |
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| 0 |
| 83 |
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | Test Denture Adhesive | Participants received test denture adhesive by site staff 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. | 0 | 83 | 0 | 83 | 0 | 83 |
| EG002 | No Adhesive (Negative Control) | Participants did not receive any denture adhesive by site staff in this treatment arm. | 0 | 83 | 0 | 83 | 0 | 83 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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