| Primary | Interproximal Mean Plaque Index at Week 4 | Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface. | Full analysis set (FAS) included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Negative Control Group (Toothbrushing Only) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks. | | OG001 | Device Control Group (Toothbrushing, Device + Water) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks. | | OG002 | Test Group (Toothbrushing, Device + Oil-containing Mouthrinse) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0002.674± 0.0432
- OG0012.213± 0.0422
- OG0022.005± 0.0422
|
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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 |
|---|
| Statistical analysis at Week 4 | ANCOVA | | <0.001 | | Difference in LS mean | -0.461 | | | 2-Sided | 95 | -0.581 | -0.341 | | | | | Superiority | | | | Statistical analysis at Week 4 | ANCOVA |
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| Primary | Whole-mouth Mean Plaque Index at Week 4 | Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface. | FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Negative Control Group (Toothbrushing Only) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks. | | OG001 | Device Control Group (Toothbrushing, Device + Water) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks. |
|
| Secondary | Interproximal Mean Modified Gingival Index (Mean MGI) at Week 2 and 4 | Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit. | FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Week 2 and 4 | | | | ID | Title | Description |
|---|
| OG000 | Negative Control Group (Toothbrushing Only) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks. | | OG001 | Device Control Group (Toothbrushing, Device + Water) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks. |
|
| Secondary | Whole-mouth Modified Gingival Index (Mean MGI) at Week 2 and 4 | Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit. | FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Week 2 and 4 | | | | ID | Title | Description |
|---|
| OG000 | Negative Control Group (Toothbrushing Only) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks. | | OG001 | Device Control Group (Toothbrushing, Device + Water) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks. |
|
| Secondary | Interproximal Mean Plaque Index (Mean PI) at Week 2 | Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface. | FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Negative Control Group (Toothbrushing Only) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks. | | OG001 | Device Control Group (Toothbrushing, Device + Water) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks. |
|
| Secondary | Whole-mouth Mean Plaque Index (Mean PI) at Week 2 | Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface. | FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Negative Control Group (Toothbrushing Only) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks. | | OG001 | Device Control Group (Toothbrushing, Device + Water) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks. |
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| Secondary | Interproximal Mean Bleeding Index (Mean BI) at Week 2 and 4 | Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding. | FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Week 2 and 4 | | | | ID | Title | Description |
|---|
| OG000 | Negative Control Group (Toothbrushing Only) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks. | | OG001 | Device Control Group (Toothbrushing, Device + Water) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks. |
|
| Secondary | Whole-mouth Mean Bleeding Index (Mean BI) at Week 2 and 4 | Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding. | FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Week 2 and 4 | | | | ID | Title | Description |
|---|
| OG000 | Negative Control Group (Toothbrushing Only) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks. | | OG001 | Device Control Group (Toothbrushing, Device + Water) | Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks. |
|