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The aim of this study is to investigate the impact of a stannous fluoride containing toothpaste in reducing gingivitis when used twice daily for a maximum for 3 weeks, when compared to a standard sodium fluoride toothpaste (negative control).
This will be a single center, controlled, single blind (examiner blind), randomized, two-treatment arm, parallel design, clinical study in participants (aged 18-65 years), with good general health (non-smokers) and generalized mild-moderate plaque-induced gingivitis and greater than equal to (>=) 20 natural teeth. The study consists of 4 study visits. At Visit 1, Screening, after signing informed consent, participants will be assessed for eligibility based on the inclusion/exclusion criteria and will undergo oral soft tissue (OST) and oral hard tissue (OHT) assessments. Participants will return between 1 and 28 days following the screening visit for the Visit 2, baseline where they will undergo, a full OST examination followed by assessments of gingival inflammation (MGI), gingival bleeding (BI) and supra-gingival plaque (TPI). Eligible participants will be stratified based on gender and baseline mean whole mouth MGI score (low: less than equal to (<=) 2.00/High greater than (>) 2.00), to ensure a balance of gingivitis across both treatment groups and then randomized to study product. All randomized participants will receive full mouth dental prophylaxis (followed by flossing) to remove sub and supra-gingival calculus, stain, plaque and debris from the teeth. All participants will enter the treatment period with no visible plaque (TPI=0). After all clinical assessments, participants will be instructed to brush for 1 timed minute at site with their assigned study product, after which they will be instructed to continue using this twice daily (morning and evening) for 2 weeks. After 2 weeks the participants will return to site for their Week 2 (Visit 3) assessments. They will then continue using their test dentifrice for a further week and will continue to record all brushing events in the diary provided, after which they will return for their Week 3 (Visit 4) assessments. All assessments will be carried out on the facial and lingual/palatal surfaces of each incisor, canine, pre-molar and molar, excluding third molars. After the Week 3 visit, study closeout procedures will take place and the participant may undergo an additional prophylaxis if it is deemed necessary by the examiner. Adverse events and incidents will be recorded from informed consent and at the end of each study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Participants with no visible plaque will be instructed to apply full ribbon of the test product (containing 0.454 percent [%] of stannous fluoride] on head of toothbrush provided and brush their teeth for 1 timed minute twice a day (morning and evening), for 3 weeks. |
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| Negative Control Dentifrice | Other | Participants with no visible plaque will be instructed to apply full ribbon of the negative control dentifrice (containing sodium fluoride) on head of toothbrush provided and brush their teeth for 1 timed minute twice a day (morning and evening), for 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensodyne Repair and Protect | Drug | Participants will brush their teeth with Sensodyne Repair and Protect (containing 0.454% stannous fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Whole Mouth Mean Bleeding Index (BI) at Week 3 | BI method used to assess gingival bleeding as measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe approximately(app.) 1millimeter(mm) into gingival sulcus (at app 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments performed 1 quadrant at a time; BI scores recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Whole Mouth Mean Bleeding Index (BI) at Week 2 | BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. |
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Inclusion Criteria:
An individual must meet all the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria:
An individual who meets any of the following exclusion criteria will not be eligible for enrollment into the study:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Las Vegas | Nevada | 89146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34511098 | Derived | Acherkouk A, Patel N, Butler A, Amini P. A randomised clinical study investigating efficacy of a stannous fluoride toothpaste in improving gingival health after 3 weeks' use. BMC Oral Health. 2021 Sep 12;21(1):441. doi: 10.1186/s12903-021-01727-5. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 154 participants were screened, of whom 130 were randomized for treatment, 17 were screen failures, 3 withdrew consent prior to randomization, and 4 were not randomized as sufficient participants were already enrolled in the study.
Participants were recruited from one center in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensodyne Repair and Protect (Test Dentifrice) | Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 percent (%) stannous fluoride (SnF2) (1100 parts per million [ppm] fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
| 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 | Jun 22, 2019 | Oct 26, 2020 |
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Single Blind
| Colgate Cavity Protection | Drug | Participants will brush their teeth with Colgate Cavity Protection repair and protect (containing sodium fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks. |
|
| Week 2 |
| Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | Number of bleeding sites were derived from the bleeding index (BI). BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. A bleeding site was a site scored as 1 or 2. Mean of all bleeding sites was calculated and reported. | Week 2 and Week 3 |
| Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | MGI used to assess for visual symptoms of gingivitis (redness, texture, edema) for all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). MGI scores were recorded as per given scoring criteria: 0- Absence of inflammation, 1- Mild inflammation: slight change in color, little change in texture of any portion of marginal or papillary gingival unit, 2- Mild inflammation: criteria as [1] but involving entire marginal or papillary gingival unit, 3- Moderate inflammation: glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit, 4- Severe inflammation: marked redness, edema and/or hypertrophy of marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower scores indicate better results. Mean whole mouth MGI score for each participant was derived from total MGI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. | Week 2 and Week 3 |
| Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 | TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth divided into 3 areas;3 scores recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria:0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque (up to 1mm) at cervical margin,3-band of plaque wider than 1mm but covering less than(<)1/3 of tooth surface,4-plaque covering more than or equal to (>=)1/3 but <2/3 of tooth surface,5-plaque covering >=2/3 of tooth surface. Lower scores indicate better results. Mean Overall TPI score for each participant was derived from total TPI score over all tooth sites divided by number of tooth sites scored. Overall mean calculated for all participants was reported. | Week 2 and Week 3 |
| Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 | TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth was divided into 3 areas; 3 scores were recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria: 0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque(up to 1 mm)at cervical margin,3-band of plaque wider than 1mm but covering <1/3 of tooth surface,4-plaque covering >=1/3 but <2/3 of tooth surface,5-plaque covering >=2/3 of tooth surface. Lower scores indicate better results. Mean Interproximal TPI score for each participant was derived from total TPI score over all interproximal tooth sites divided by number of interproximal tooth sites scored. Mean calculated for all participants was reported. | Week 2 and Week 3 |
| FG001 | Colgate Cavity Protection (Negative Control Dentifrice) | Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as sodium monofluorophosphate (SMFP) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all randomized participants who received at least one dose of the study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensodyne Repair and Protect (Test Dentifrice) | Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
| BG001 | Colgate Cavity Protection (Negative Control Dentifrice) | Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Whole Mouth Mean Bleeding Index (BI) at Week 3 | BI method used to assess gingival bleeding as measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe approximately(app.) 1millimeter(mm) into gingival sulcus (at app 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments performed 1 quadrant at a time; BI scores recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. | Modified intent-to-treat (m-ITT) population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number of participants analyzed indicates participants with available data for this outcome measure at specified time point. | Posted | Mean | Standard Deviation | score on a scale | Week 3 |
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| Secondary | Whole Mouth Mean Bleeding Index (BI) at Week 2 | BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. | m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | score on a scale | Week 2 |
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| Secondary | Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 | Number of bleeding sites were derived from the bleeding index (BI). BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. A bleeding site was a site scored as 1 or 2. Mean of all bleeding sites was calculated and reported. | m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point. | Posted | Mean | Standard Deviation | number of bleeding sites | Week 2 and Week 3 |
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| Secondary | Mean Modified Gingival Index (MGI) at Week 2 and Week 3 | MGI used to assess for visual symptoms of gingivitis (redness, texture, edema) for all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). MGI scores were recorded as per given scoring criteria: 0- Absence of inflammation, 1- Mild inflammation: slight change in color, little change in texture of any portion of marginal or papillary gingival unit, 2- Mild inflammation: criteria as [1] but involving entire marginal or papillary gingival unit, 3- Moderate inflammation: glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit, 4- Severe inflammation: marked redness, edema and/or hypertrophy of marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower scores indicate better results. Mean whole mouth MGI score for each participant was derived from total MGI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. | m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point. | Posted | Mean | Standard Deviation | score on a scale | Week 2 and Week 3 |
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| Secondary | Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 | TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth divided into 3 areas;3 scores recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria:0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque (up to 1mm) at cervical margin,3-band of plaque wider than 1mm but covering less than(<)1/3 of tooth surface,4-plaque covering more than or equal to (>=)1/3 but <2/3 of tooth surface,5-plaque covering >=2/3 of tooth surface. Lower scores indicate better results. Mean Overall TPI score for each participant was derived from total TPI score over all tooth sites divided by number of tooth sites scored. Overall mean calculated for all participants was reported. | m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point. | Posted | Mean | Standard Deviation | score on a scale | Week 2 and Week 3 |
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| Secondary | Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 | TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth was divided into 3 areas; 3 scores were recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria: 0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque(up to 1 mm)at cervical margin,3-band of plaque wider than 1mm but covering <1/3 of tooth surface,4-plaque covering >=1/3 but <2/3 of tooth surface,5-plaque covering >=2/3 of tooth surface. Lower scores indicate better results. Mean Interproximal TPI score for each participant was derived from total TPI score over all interproximal tooth sites divided by number of interproximal tooth sites scored. Mean calculated for all participants was reported. | m-ITT population was defined as all participants who were randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy. Here, number analyzed indicates participants with available data at specified time point. | Posted | Mean | Standard Deviation | score on a scale | Week 2 and Week 3 |
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Up to 28 days
Safety population included all randomized participants who received at least one dose of the study product.All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
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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 | Sensodyne Repair and Protect (Test Dentifrice) | Participants randomized to this group brushed their teeth with Sensodyne Repair and Protect containing 0.454 % SnF2 (1100 ppm fluoride) for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. | 0 | 65 | 0 | 65 | 4 | 65 |
| EG001 | Colgate Cavity Protection (Negative Control Dentifrice) | Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. | 0 | 65 | 0 | 65 | 3 | 65 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival injury | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
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| Traumatic ulcer | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
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| Gingival ulceration | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
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| Angular cheilitis | Infections and infestations | MedDRA version 22.1 | 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 | Oct 4, 2019 | Oct 26, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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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| OG001 | Colgate Cavity Protection (Negative Control Dentifrice) | Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
|
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| OG001 | Colgate Cavity Protection (Negative Control Dentifrice) | Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
|
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| OG001 | Colgate Cavity Protection (Negative Control Dentifrice) | Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
|
|
| OG001 | Colgate Cavity Protection (Negative Control Dentifrice) | Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
|
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| OG001 | Colgate Cavity Protection (Negative Control Dentifrice) | Participants randomized to this group brushed their teeth with Colgate Cavity Protection containing 1100 ppm fluoride as SMFP for 1 timed minute twice a day (morning and evening) in their usual manner for 3 weeks. Participants recorded each brushing event in their dairy along with, any changes to these brushing procedures along with reasons for changes (e.g., missed brushings, extra brushings) and the actual time of the last brushing before attending site, on the day before the next visit. |
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