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| ID | Type | Description | Link |
|---|---|---|---|
| RH02433 | Other Identifier | GSK |
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The primary objectives of this study will be to compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Silverstone Research Group. Participants will be recruited from their database and by use of an external recruitment agency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate plus sodium fluoride | Experimental | Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
|
| Sodium fluoride | Active Comparator | Toothpaste containing 1100 ppm fluoride as sodium fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate plus sodium fluoride | Drug | Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Gingival Bleeding Sites at 24 Weeks | Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. | Baseline, 24 weeks |
| Modified Gingival Index (MGI) at 24 Weeks | The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. |
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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 | Las Vegas | Nevada | 89146 | United States |
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The participants were recruited at a clinical site in the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Bicarbonate Dentrifice | Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| FG001 | 0% Sodium Bicarbonate Dentrifice | Toothpaste containing 1100 ppm fluoride as sodium fluoride |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Bicarbonate Dentrifice | Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| BG001 | 0% Sodium Bicarbonate Dentrifice |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Gingival Bleeding Sites at 24 Weeks | Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Error | number of gingival bleeding sites | Baseline, 24 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 | Sodium Bicarbonate Dentrifice | Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MOUTH INJURY | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Sodium fluoride | Drug | Toothpaste containing 1100 ppm fluoride as sodium fluoride |
|
| Baseline, 6 and 12 weeks |
| Modified Gingival Index (MGI) at 6 and 12 Weeks. | MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration | Baseline, 6 and 12 weeks |
| Bleeding Index at 6, 12 and 24 Weeks | The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed | Baseline, 6, 12 and 24 weeks |
| Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks. | The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth | Baseline, 6,12 and 24 weeks |
| Did not meet study criteria |
|
| Pregnancy |
|
Toothpaste containing 1100 ppm fluoride as sodium fluoride
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 0% Sodium Bicarbonate Dentrifice | Toothpaste containing 1100 ppm fluoride as sodium fluoride |
|
|
|
| Primary | Modified Gingival Index (MGI) at 24 Weeks | The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Mean | Standard Error | Units on a scale | Baseline, 24 weeks |
|
|
|
|
| Secondary | Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Mean | Standard Error | number of gingival bleeding sites | Baseline, 6 and 12 weeks |
|
|
|
| Secondary | Modified Gingival Index (MGI) at 6 and 12 Weeks. | MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Mean | Standard Error | Units on a scale | Baseline, 6 and 12 weeks |
|
|
|
| Secondary | Bleeding Index at 6, 12 and 24 Weeks | The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Mean | Standard Error | Units on a Scale | Baseline, 6, 12 and 24 weeks |
|
|
|
| Secondary | Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks. | The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth | Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Mean | Standard Error | Units on a scale | Baseline, 6,12 and 24 weeks |
|
|
|
| 0 |
| 124 |
| 7 |
| 124 |
| EG001 | 0% Sodium Bicarbonate Dentrifice | Toothpaste containing 1100 ppm fluoride as sodium fluoride | 0 | 123 | 8 | 123 |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications |
|
| THERMAL BURN | Injury, poisoning and procedural complications |
|
| BRONCHITIS | Infections and infestations |
|
| NASOPHARYNGITIS | Infections and infestations |
|
| OVARIAN CYST RUPTURED | Respiratory, thoracic and mediastinal disorders |
|
| ABDOMINAL PAIN | Gastrointestinal disorders |
|
| GINGIVAL PAIN | Gastrointestinal disorders |
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| SENSITIVITY OF TEETH | Gastrointestinal disorders |
|
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.
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Number of Bleeding sites after 12 weeks |
|
| Modified Gingival Index after 12 weeks |
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| Bleeding Index Score after 12 weeks |
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| Bleeding Index Score after 24 weeks |
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| Overall Plaque Score after 12 weeks |
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| Overall Plaque Score after 24 weeks |
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| Interproximal Plaque Score at Baseline |
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| Interproximal Plaque Score after 6 weeks |
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| Interproximal Plaque Score after 12 weeks |
|
| Interproximal Plaque Score after 24 weeks |
|