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Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stannous Fluoride Toothpaste | Experimental | brush for 2 min, 2x/day, morning and night |
|
| Sodium monofluorophosphate toothpaste | Active Comparator | brush for 2 min, 2x/day, morning and night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous fluoride toothpaste | Drug | brush 2 min morning & night daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Loe and Silness Gingival Index. | A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored. | baseline, one week, six weeks and three months |
| Quigley and Hein Plaque Index | A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored. | baseline, one week, six weeks and three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terdphong Triratana | M U International Oral Science Research, Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahidol University | Ratchathewi | Bangkok | 10400 | Thailand |
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| Colgate Cavity Protection Toothpaste |
| Drug |
brush 2 min morning & night daily |
|
| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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