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The purpose of this study is to determine whether spherical silica can achieve similar or greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing higher concentrations of standard abrasive silica, and how the addition of 5% sodium tripolyphosphate (STP) enhances cleaning capability.
This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm, parallel design study will be conducted in healthy participants with a propensity for extrinsic dental stain (based on the judgement of the examiner) on the facial surfaces of the anterior teeth. This study will be used to evaluate and compare the extrinsic dental stain and plaque removal of an experimental low abrasivity 0.5% spherical silica dentifrice and a marketed low abrasivity 6% standard silica abrasive dentifrice, and an experimental moderate abrasivity 1% spherical silica / 5% STP dentifrice and a marketed high abrasivity 16% standard abrasive silica / 5% STP dentifrice. Stain will be assessed using an established clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain index (MLSI). Particpants will be stratified by baseline MLSI score (total MLSI (area [A] × intensity [I]) for the facial surfaces of the 4 anterior assessment teeth). Plaque will be assessed using an established clinical measure of plaque - the Turesky Modification of the Quigley Hein Index. Stain and plaque will be assessed at intervals over an 8 week treatment period. Plaque will be assessed at baseline and Week 8 only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product 1 | Experimental | Participants will be instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica. |
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| Test Product 2 | Experimental | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP. |
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| Reference Product 1 | Active Comparator | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. |
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| Reference Product 2 | Active Comparator | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica | Drug | Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks. | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score). | Baseline, Week 8 post treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1) | An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 1 and reference product 1 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fort Wayne | Indiana | 46825 | United States |
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A total of 137 participates were screened, out of which 123 participants were enrolled and randomized in the study. 14 participants were not randomized as 11 participants did not meet study criteria, 2 participants withdrew by consent and 1 participant was lost to follow-up.
Participants were recruited from one center in USA
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product 1 | Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica. |
| FG001 | Test Product 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 24, 2017 | Nov 19, 2018 |
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| 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP | Drug | Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner). |
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| 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica | Drug | Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner). |
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| 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP | Drug | Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner). |
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| Baseline, Week 8 post treatment administration |
| Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2) | An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 2 and reference product 2 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score). | Baseline, Week 8 post treatment administration |
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% sodium tripolyphosphate (STP).
| FG002 | Reference Product 1 | Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. |
| FG003 | Reference Product 2 | Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP. |
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| NOT COMPLETED |
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Safety population (N=123) comprised of all participants who were randomized and received at least one dose of study treatment during the study. This population was based on the treatment the participant actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product 1 | Participants were instructed to apply experimental dentifrice containing 5% KNO3) / 0.2542% NaF dentifrice with 0.5% spherical silica. |
| BG001 | Test Product 2 | Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP. |
| BG002 | Reference Product 1 | Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. |
| BG003 | Reference Product 2 | Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP. |
| BG004 | Total | Total of all reporting groups |
| 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 | ||||||||||
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| Age, Customized | Mean | Standard Deviation | 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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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks. | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score). | The Intent-to-Treat (ITT) (n=123) population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 8 post treatment administration |
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| Secondary | Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1) | An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 1 and reference product 1 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score). | The ITT population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 8 post treatment administration |
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| Secondary | Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2) | An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 2 and reference product 2 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score). | The ITT population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 8 post treatment administration |
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8 weeks
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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 Product 1 | Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica. | 0 | 31 | 0 | 31 | 3 | 31 |
| EG001 | Test Product 2 | Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP. | 0 | 31 | 0 | 31 | 1 | 31 |
| EG002 | Reference Product 1 | Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. | 0 | 30 | 0 | 30 | 2 | 30 |
| EG003 | Reference Product 2 | Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP. | 0 | 31 | 0 | 31 | 0 | 31 |
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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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| LIP ULCERATION | Gastrointestinal disorders | Systematic Assessment |
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| MOUTH ULCERATION | Gastrointestinal disorders | Systematic Assessment |
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| PALATAL ULCER | Gastrointestinal disorders | Systematic Assessment |
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| ANGULAR CHEILITIS | Infections and infestations | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2018 | Nov 19, 2018 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| ANCOVA | From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate. | 0.5680 | Difference of Least Square mean | -0.07 | Standard Error of the Mean | 0.128 | 2-Sided | 95 | -0.33 | 0.18 | -0.33 to 0.18 | Other |
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