Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | commercially available Fluoride toothpaste |
|
| B | Active Comparator | fluoride/triclosan/copolymer toothpaste |
|
| C | Experimental | fluoride/herbal toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Brush twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental Plaque | Quigley Hein Method: 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. Plaque score= sum of all scores divided by the number of sites (teeth) scored. | 6 weeks |
| Gingivitis Score | Gingivitis score (GI)= 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 scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored. | 6 weeks |
| Bleeding Index (EIBI) | Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100. | 6 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yanfang Ren, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastman Dental Center - University of Rochester | Rochester | New York | 14642-8315 | United States |
subjects were screened for meeting medical and oral health criteria. Then completed a 1 week washout period with fluoride toothpaste prior to receiving any study treatments.
subjects were recruited by the PI at the clinical site
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A- Placebo Comparator | Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste) |
| FG001 | B - Active Comparator | fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste) |
| FG002 | C - Experimental Toothpaste | fluoride/herbal toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A- Placebo Comparator | Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste) |
| BG001 | B - Active Comparator | fluoride/triclosan/copolymer toothpaste (Colgate Total 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 | Dental Plaque | Quigley Hein Method: 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. 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 (1 week washout period + 6 week study test period)
Not provided
Not provided
| 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 | Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Devizio | Colgate Palmolive Co. | 732-878-7901 | William_Devizio@colpal.com |
Not provided
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Triclosan and fluoride | Drug | Brush twice daily |
|
|
| Herbal Ingredient and fluoride | Drug | Brush twice daily |
|
| BG002 | C - Experimental Toothpaste | fluoride/herbal 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 |
|
| OG002 | C - Experimental Toothpaste | fluoride/herbal toothpaste |
|
|
|
| Primary | Gingivitis Score | Gingivitis score (GI)= 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 scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored. | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
|
|
|
|
| Primary | Bleeding Index (EIBI) | Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100. | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | B - Active Comparator | fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste) | 0 | 34 | 0 | 34 |
| EG002 | C - Experimental Toothpaste | fluoride/herbal toothpaste | 0 | 35 | 0 | 35 |
Not provided
| 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 |