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A clinical research study design to compare the effectiveness of a battery toothbrush and dentifrice in reducing gingivitis and dental plaque in adults.
This is a Phase III, randomized, single-center, parallel group, double blind, clinical research study design to compare the effectiveness of a battery toothbrush and dentifrice in reducing gingivitis and dental plaque in adults. This study will have 3 arms to determine the efficacy of a battery toothbrush vs a positive control regimen and a negative control regimen to reduce plaque and gingivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 | Experimental | instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided. |
|
| Test 2 | Active Comparator | instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided. |
|
| Test 3 | Active Comparator | instructed to brush their teeth for two (2) minutes twice a day (morning and evening) with the toothpaste and toothbrush provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Active Prevention Fresh Toothpaste + Colgate Total Active Prevention Battery Toothbrush | Drug | 0.454 Stannous Fluoride toothpaste with battery toothbrush |
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| Measure | Description | Time Frame |
|---|---|---|
| Löe and Silness Gingival Index | score from 0 to 3 will be assigned by the examining dentist to all scorable 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 scorable surface and dividing that number by the total number of surfaces scored. | baseline,6 week, 12 week |
| Rustogi Mod. Navy Plaque Index | An expanded form of the Rustogi Modified Navy Plaque Index, used to measure plaque on different surfaces of teeth. Plaque disclosing solution used | baseline, 6 week, 12 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Augusto R. Elias-Boneta, DMD.MSD | Dental Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Research Associates, Inc. | San Juan | 00927 | Puerto Rico |
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| Colgate Great Regular + Total Active Prevention Battery Toothbrush | Drug | regular fluoride toothpaste with battery toothbrush |
|
| Colgate Great Regular + standard reference flat trim toothpaste | Drug | regular fluoride toothpaste with manual toothbrush |
|
| 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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