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The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A -Experimental toothpaste | Active Comparator | triclosan/copolymer/fluoride toothpaste |
|
| B - control toothpaste | Placebo Comparator | sodium fluoride only toothpaste (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan, fluoride | Drug | Six Month study, brush twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gingivitis Index | 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) | 6 months |
| Plaque Index | 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) | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Augusto E Boneta, DDS | Dental Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Fernando Autran | Barcelona | Spain |
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Performed by the Research Department School of Dentistry UPR
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Treatment | triclosan/copolymer/fluoride toothpaste |
| FG001 | Placebo Control | sodium fluoride toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Treatment | triclosan/copolymer/fluoride toothpaste |
| BG001 | Placebo Control | sodium 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 | Gingivitis Index | 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) | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
6 months
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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 | Experimental Treatment | triclosan/copolymer/fluoride toothpaste |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William De Vizio, DMD | Colgate Palmolive | 732-878-7901 | William_Devizio@colpal.com |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014260 | Triclosan |
| D005459 | Fluorides |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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| Fluoride | Drug | twice daily usage |
|
|
| BG002 | 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Plaque Index | 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) | Per protocol | Posted | Mean | Standard Deviation | Units on a scale | 6 Months |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Placebo Control | sodium fluoride toothpaste | 0 | 60 | 0 | 60 |
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| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |