| Primary | Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste) | Gingival bleeding was assessed according to the expanded bleeding index (EBI), by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth were assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. | The modified Intention-To-Treat (mITT) population comprised of all randomized participants who received at least one dose of investigational product and completed at least one-post Baseline efficacy assessment. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | bleeding sites | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | Participants brushed their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00010.1± 1.03
- OG00124.1± 1.05
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Van Elteren Test | | <0.0001 | Method used for estimates and P-values was MMRM. Where MMRM assumptions are violated, a supportive non-parametric P-value is used (Van Elteren Test) and presented here. | Adjusted Mean Difference | -14.0 | Standard Error of the Mean | 1.48 | 2-Sided | 95 | -16.9 | -11.1 | | | | | Superiority | | |
|
| Secondary | Interproximal NBS at Week 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | bleeding sites | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | |
|
| Secondary | Overall NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | bleeding sites | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | |
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| Secondary | Interproximal NBS at Week 6 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. | | Posted | | Least Squares Mean | Standard Error | bleeding sites | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | Participants brushed their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. |
|
| Secondary | Mean Overall Bleeding Index (Bl) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale ranging from 0 to 2, where 0 equal to (=) no bleeding after 30 seconds; 1=bleeding observed within 30 seconds of probing; 2=bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. | | OG001 |
|
| Secondary | Mean Interproximal BI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale ranging from 0 to 2, where 0=no bleeding after 30 seconds; 1=bleeding observed within 30 seconds of probing; 2=bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) |
|
| Secondary | Mean Overall Modified Gingival Index (MGI) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | The MGI assessment was a non-invasive evaluation which focused on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; little change in texture of any portion of the marginal or papillary gingival unit; 2=Mild inflammation; criteria as 1 but involving the entire marginal or papillary gingival unit; 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. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. |
|
| Secondary | Mean Interproximal MGI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | The MGI assessment was a non-invasive evaluation which focused on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; little change in texture of any portion of the marginal or papillary gingival unit; 2=Mild inflammation; criteria as 1 but involving the entire marginal or papillary gingival unit; 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. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. |
|
| Secondary | Mean Overall Turesky Plaque Index (TPI) at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores were recorded buccally/labially (distal, body, mesial sites) and three scores lingually/ palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was scored on a 6-point scale ranging from 0 to 5, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin, continuous band of plaque (up to 1 millimeter[mm]) at the cervical margin, 3= Band of plaque wider than 1 mm but covering less than (<)1/3 of the tooth surface, 4= Plaque covering greater than or equal to (>=) 1/3 but < 2/3 of the tooth surface, 5= Plaque covering >= 2/3 of the tooth surface. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. | |
|
| Secondary | Mean Interproximal TPI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste) | The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores were recorded buccally/labially (distal, body, mesial sites) and three scores lingually/palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was scored on a 6-point scale ranging from 0 to 5, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin, continuous band of plaque (up to 1 mm) at the cervical margin, 3= Band of plaque wider than 1 mm but covering <1/3 of the tooth surface, 4= Plaque covering >= 1/3 but < 2/3 of the tooth surface, 5= Plaque covering >= 2/3 of the tooth surface. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) | Participants brushed their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants swished 20 mL of mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) |
|
| Secondary | Overall NBS at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | bleeding sites | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Reference Toothpaste (SnF2 Toothpaste) | Participants brushed their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | Participants brushed their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. |
|
| Secondary | Interproximal NBS at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | bleeding sites | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Reference Toothpaste (SnF2 Toothpaste) | Participants brushed their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | Participants brushed their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. |
|
| Secondary | Mean Overall BI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale ranging from 0 to 2, where 0=no bleeding after 30 seconds; 1=bleeding observed within 30 seconds of probing; 2=bleeding observed immediately on probing. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Reference Toothpaste (SnF2 Toothpaste) | Participants brushed their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | |
|
| Secondary | Mean Interproximal BI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) | Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale ranging from 0 to 2, where 0=no bleeding after 30 seconds; 1=bleeding observed within 30 seconds of probing; 2=bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Reference Toothpaste (SnF2 Toothpaste) | Participants brushed their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | Participants brushed their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. |
|
| Secondary | Mean Overall MGI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) | The MGI assessment was non-invasive evaluation which focuses on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; little change in texture of any portion of the marginal or papillary gingival unit; 2=Mild inflammation; criteria as 1 but involving the entire marginal or papillary gingival unit; 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. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Reference Toothpaste (SnF2 Toothpaste) | Participants brushed their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) |
|
| Secondary | Mean Interproximal MGI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) | The MGI assessment was non-invasive evaluation which focuses on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; little change in texture of any portion of the marginal or papillary gingival unit; 2=Mild inflammation; criteria as 1 but involving the entire marginal or papillary gingival unit; 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. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Reference Toothpaste (SnF2 Toothpaste) | Participants brushed their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) |
|
| Secondary | Mean Overall TPI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) | The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores was recorded buccally/labially (distal, body, mesial sites) and three scores lingually/palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was scored on a 6-point scale ranging from 0 to 5, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin, continuous band of plaque (up to 1 mm) at the cervical margin, 3= Band of plaque wider than 1 mm but covering <1/3 of the tooth surface, 4= Plaque covering >= 1/3 but < 2/3 of the tooth surface, 5= Plaque covering >= 2/3 of the tooth surface. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Reference Toothpaste (SnF2 Toothpaste) | Participants brushed their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | Participants brushed their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. |
|
| Secondary | Mean Interproximal TPI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste) | The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores were recorded buccally/labially (distal, body, mesial sites) and three scores lingually/palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was scored on a 6-point scale ranging from 0 to 5, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin, continuous band of plaque (up to 1 mm) at the cervical margin, 3= Band of plaque wider than 1 mm but covering <1/3 of the tooth surface, 4= Plaque covering >= 1/3 but < 2/3 of the tooth surface, 5= Plaque covering >= 2/3 of the tooth surface. Lower score indicated improvement in the symptoms. | mITT Population. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Reference Toothpaste (SnF2 Toothpaste) | Participants brushed their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. | | OG001 | Negative Control Toothpaste (Sodium Fluoride Toothpaste) | Participants brushed their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. |
|