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This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride - A | Placebo Comparator | Fluoride only toothpaste |
|
| Total + Whitening toothpaste - B | Active Comparator | Triclosan/fluoride toothpaste |
|
| Triclosan/fluoride/Amino Acid - C | Experimental | toothpaste containing amino acid #1 |
|
| Triclosan/fluoride/Cavistat -D | Experimental | toothpaste containing amino acid/bicarbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Brush two times a day for 4 days. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental Plaque Index | plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque. | 4-Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Corby, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bluestone Center for Clinical Research, NYU College of Dentistry | New York | New York | 10016 | United States |
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At clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoride First | Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last |
| FG001 | Triclosan/Fluoride First | Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last |
| FG002 | Triclosan/Fluoride/Arginine First | Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last |
| FG003 | Triclosan/Fluoride/Cavistat First | Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Intervention |
| |||||||||||||
| Washout After 1st Intervention |
| |||||||||||||
| 2nd Intervention Order |
| |||||||||||||
| Washout After 2nd Intervention |
| |||||||||||||
| 3rd Intervention |
| |||||||||||||
| Washout After 3rd Intervention |
| |||||||||||||
| 4th Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoride - A | Negative control |
| BG001 | Fluoride/Triclosan - B | Positive control comparator |
| 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 Index | plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque. | Posted | Mean | Standard Deviation | Units on a scale | 4-Day |
|
8 weeks (including all washout periods and four (4) study intervention periods of 4 days each).
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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 | Fluoride First | Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last |
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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 |
| C012980 | fluorophosphate |
| D014260 | Triclosan |
| D012969 | Sodium Fluoride |
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Triclosan/Fluoride | Drug | Brush two times daily for 4 days |
|
|
| Triclosan/Fluoride | Drug | Brush twice daily for 4 days |
|
|
| Triclosan/Fluoride | Drug | Brush twice daily for 4 days |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 |
| Triclosan/Fluoride/Arginine |
toothpaste containing amino acid |
| BG003 | Triclosan/Fluoride/Cavistat | toothpaste containing bicarbonate |
| BG004 | 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 |
|
| OG003 |
| Triclosan/Fluoride/Cavistat |
toothpaste containing bicarbonate |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Triclosan/Fluoride First | Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last | 0 | 29 | 0 | 29 |
| EG002 | Triclosan/Fluoride/Arginine First | Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last | 0 | 29 | 0 | 29 |
| EG003 | Triclosan/Fluoride/Cavistat First | Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last | 0 | 29 | 0 | 29 |
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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 |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000602 | Amino Acids, Peptides, and Proteins |