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Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride control -A | Placebo Comparator | Winterfresh Gel |
|
| Triclosan/Fluoride - B | Active Comparator | Positive control (Total toothpaste) |
|
| Triclosan/fluoride/metal salt- C | Experimental | test toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Brush twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | Plaque Index score 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) | 6 weeks |
| Gingivitis Index | Gingivitis score- 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) | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salim A Nathoo, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Clinical Research | Cedar Knolls | New Jersey | 07927 | United States |
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At the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Control | fluoride toothpaste (Winterfresh Gel) |
| FG001 | Positive Control | triclosan/fluoride toothpaste |
| FG002 | Experimental | triclosan/fluoride/metal salt toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Control | fluoride toothpaste |
| BG001 | Positive Control | triclosan/fluoride toothpaste |
| 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 | Plaque Index | Plaque Index score 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) | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
|
7 weeks (1 week washout and 6 week study test period)
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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 | Placebo Control | fluoride toothpaste (Winterfresh Gel) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William DeVizio - DMD | Colgate Palmolive | 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 |
| C408633 | Colgate Winterfresh Fluoride Gel |
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| C000715613 | ZIF-8 metal-organic framework |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Triclosan, fluoride | Drug | Brush twice daily |
|
|
| Metal salt | Other | Brush twice daily |
|
|
| BG002 |
| Experimental |
triclosan/fluoride/zinc toothpaste |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
triclosan/fluoride/metal salt toothpaste |
|
|
|
| Primary | Gingivitis Index | Gingivitis score- 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) | Posted | Mean | Standard Deviation | Units on a scale | 6 Weeks |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Positive Control | triclosan/fluoride toothpaste | 0 | 34 | 0 | 34 |
| EG002 | Experimental | triclosan/fluoride/metal salt toothpaste | 0 | 34 | 0 | 34 |
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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 |