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The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.76% Sodium Monofluorophosphate Dentifrice | Sham Comparator |
| |
| Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice | Active Comparator |
| |
| Marketed 0.454% Stannous Fluoride Dentifrice | Active Comparator |
| |
| 0.454% Stannous Fluoride Dentifrice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.76% Sodium Monofluorophosphate Dentifrice | Drug | Whole mouth brushing with a toothpaste, twice daily for the duration of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | Baseline |
| Löe-Silness Gingivitis Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHRG | Whittier | California | 90602 | United States |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| 0.454% Stannous Fluoride Dentifrice | Drug | Whole mouth brushing with a toothpaste, twice daily for the duration of the study. |
|
| 0.454% Stannous Fluoride Dentifrice | Drug | Whole mouth brushing with a toothpaste, twice daily for the duration of the study. |
|
| 0.454% Stannous Fluoride Dentifrice | Drug | Whole mouth brushing with a toothpaste, twice daily for the duration of the study. |
|
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). |
| 1 Month |
| Mean Turesky Modified Quigley-Hein Index | The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth. | Baseline |
| Mean Turesky Modified Quigley-Hein Index | The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth. | 1 Month |
| Mean Turesky Modified Quigley-Hein Index | The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth. | 3 Months |
| D009057 |
| Stomatognathic Diseases |