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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | 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. |
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| Positive Control | Active Comparator | 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. |
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| Negative Control | Other | Participants of this group will not be assigned to any treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product | Other | Five strips of test adhesive cream for upper denture, as per application instructions. |
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| 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 |
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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 | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31249709 | Derived | Varghese R, Burnett GR, Souverain A, Patil A, Gossweiler AG. A randomised bite force study assessing two currently marketed denture adhesive products compared with no-adhesive control. Clin Exp Dent Res. 2019 May 14;5(3):276-283. doi: 10.1002/cre2.182. eCollection 2019 Jun. |
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A total of 53 participants were screened. Out of which 44 participants were randomized in the study. 9 participants were not randomized because they did not meet the study criteria.
All participants were recruited at a single center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Adhesive/No Treatment/Positive Control Adhesive | Participants in this arm received topical application of test adhesive, followed by no treatment, positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products were applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. |
| FG001 | Test Adhesive/Positive Control Adhesive/No Treatment | Participants in this arm received topical application of test adhesive, followed by positive control adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. |
| FG002 | No Treatment/Test Adhesive/Positive Control Adhesive | Participants in this arm received no treatment, followed by topical application of test adhesive and positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. |
| FG003 | No Treatment/Positive Control Adhesive/Test Adhesive | Participants in this arm received no treatment, followed by topical application of positive control adhesive and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. |
| FG004 | Positive Control Adhesive/Test Adhesive/No Treatment | Participants in this arm received topical application of positive control adhesive, followed by test adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. |
| FG005 | Positive Control Adhesive/No Treatment/Test Adhesive | Participants in this arm received topical application of positive control adhesive, followed by no treatment and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Wash Out Period 1 |
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| Period 2 |
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| Wash Out Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | All randomized participants who received test adhesive, positive control adhesive and did not receive any treatment 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 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. | Analysis for this outcome was performed on intention-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy. | Posted | Least Squares Mean | Standard Error | lbs | Up to 12 hours |
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up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
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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 | Participants of this arm received topical application of test adhesive (commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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 | Mar 17, 2017 | Apr 11, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2017 | Apr 17, 2018 | SAP_001.pdf |
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| Positive Contol | Other | Three dabs of positive control adhesive cream for upper denture, as per application instructions. |
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| Negative Control | Other | No adhesive |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Negative Control | Participants of this arm did not receive any adhesive to apply on upper denture. |
|
|
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| Primary | 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. | Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. | Posted | Least Squares Mean | Standard Error | lbs | Up to 12 hours |
|
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 2 |
| 42 |
| EG001 | Positive Control Adhesive | Participants of this arm received topical application of positive control adhesive (super poligrip free, commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. | 0 | 43 | 0 | 43 | 2 | 43 |
| EG002 | Negative Control | Participants of this arm did not receive any adhesive to apply on upper denture. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG003 | Overall Participants | This arm included all the participants randomized to receive test adhesive, positive control adhesive and no treatment. | 0 | 44 | 0 | 44 | 4 | 44 |
| Mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Gingival erythema | Gastrointestinal disorders | Systematic Assessment |
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| Oral mucosal erythema | Gastrointestinal disorders | Systematic Assessment |
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| Medical device pain | General disorders | Systematic Assessment |
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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.