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The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite force study will be to compare bite force measurements over a 12 hour period across two (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control.
This will be a 4-treatment, 4-period, randomized, crossover, proof of principle bite force study which will compare bite force measurements over a 12 hour period across two cream denture adhesives with a currently marketed cream denture adhesive (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 administered to give an indication of participant satisfaction of these attributes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product 1 | Experimental | Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions. |
|
| Test Product 2 | Experimental | Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions. |
|
| Reference Product | Active Comparator | Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions. |
|
| Negative Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product 1 | Device | Test adhesive 1 with a thin nozzle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive | 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 Test Adhesive 2 vs. No Adhesive | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive | 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. |
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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 | Bloomfield | New Jersey | 07003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32026625 | Derived | Atassi M, Ling MR, Oneglia K, Dilauro TS. A proof-of-principle bite force study using two experimental test denture adhesives and a currently marketed denture adhesive. Clin Exp Dent Res. 2020 Apr;6(2):266-273. doi: 10.1002/cre2.256. Epub 2020 Feb 6. |
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A total of 37 participants were screened. Out of which 23 participants were randomized in the study. 14 participants were not randomized in the study because 12 of which were screened failure, one participant withdrew consent and one participant was dismissed because number of participants required being reached.
All participants were recruited at a single center in USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | This was a single-center, randomized, controlled, examiner-blind, four-treatment, four-period, crossover study. Participants received a single application of each study treatment, lasting for 12 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | All randomized participants who received all four treatments: test adhesive 1, test adhesive 2, positive control adhesive and no adhesive were included in the baseline assessment. |
| Units | Counts |
|---|---|
| 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 | Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive | 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. | Analysis for this outcome was performed on intent-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome. | Posted | Least Squares Mean | Standard Error | lbs | up to 12 hours |
|
up to 61 days (AEs were collected from OST examination from screening to last study visit)
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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 | Test Adhesive 1 | Participants of this arm received topical application of test adhesive 1 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Traumatic ulcer | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2017 | Feb 26, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2017 | Feb 26, 2018 | SAP_001.pdf |
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| Test Product 2 |
| Device |
Test adhesive 2 with a thin nozzle |
|
| Reference Product | Device | Adhesive Cream |
|
| Negative Control | Other | No adhesive |
|
| up to 12 hours |
| Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive | 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 |
| Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2 | 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
| OG001 | No Adhesive | Participants of this arm did not receive any adhesive to apply on upper denture. |
|
|
|
| Primary | Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive | 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. | Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome. | Posted | Least Squares Mean | Standard Error | lbs | up to 12 hours |
|
|
|
|
| Secondary | Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive | 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. | Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome. | Posted | Least Squares Mean | Standard Error | lbs | up to 12 hours |
|
|
|
|
| Secondary | Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive | 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. | Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome. | Posted | Least Squares Mean | Standard Error | lbs | up to 12 hours |
|
|
|
|
| Secondary | Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2 | 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. | Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome. | Posted | Least Squares Mean | Standard Error | lbs | up to 12 hours |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Test Adhesive 2 | Participants of this arm received topical application of test adhesive 2 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions. | 0 | 22 | 0 | 22 | 3 | 22 |
| EG002 | Positive Control Adhesive | Participants of this arm received topical application of commercial adhesive to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions. | 0 | 21 | 0 | 21 | 2 | 21 |
| EG003 | Negative Control | Participants of this arm did not receive any adhesive to apply on upper denture. | 0 | 20 | 0 | 20 | 0 | 20 |
| abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Gingival ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Injury associated with device | General disorders | Systematic Assessment |
|
| Device breakage | Product Issues | Systematic Assessment |
|
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.