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The objective is to compare two commerical oral products for the treatment of gingivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | commercially available Fluoride only toothpaste |
|
| B | Active Comparator | Commercially available triclosan/copolymer/fluoride toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Brush teeth two times daily for 6 weeks |
| |
| Triclosan |
| Measure | Description | Time Frame |
|---|---|---|
| Control Established Plaque in Adults | Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Control Gingivitis in Adults | Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis Kinane, BDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville, School of Dentistry | Louisville | Kentucky | 40292 | United States |
Screening for subjects that met the overall oral health criteria. Followed by a 1 week washout prior to starting any study treatments or procedures.
subjects recruited by the PI at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | A -Placebo Comparator | Fluoride toothpaste |
| FG001 | B- Active Comparator | Fluoride/triclosan toothpaste (Total) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A -Placebo Comparator | Fluoride toothpaste |
| BG001 | B- Active Comparator | Fluoride/triclosan toothpaste (Total) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Control Established Plaque in Adults | Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored. | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
|
7 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A -Placebo Comparator | Fluoride toothpaste |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Devizio | Colgate Palmolive Co. | 732-878-7901 | William_Devizio@colpal.com |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005459 | Fluorides |
| D014260 | Triclosan |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Drug |
Brush two times daily for 6 weeks |
|
| Fluoride | Drug | Brush two times daily for 6 weeks |
|
| 6 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Control Gingivitis in Adults | Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored). | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | B- Active Comparator | Fluoride/triclosan toothpaste (Total) | 0 | 22 | 0 | 22 |
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| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |