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Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride toothpaste | Placebo Comparator | negative control toothpaste |
|
| Triclosan/Fluoride toothpaste | Active Comparator | positive control toothpaste (Total toothpaste) |
|
| Chlorhexidine Oral Rinse | Active Comparator | positive control oral rinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Brush half mouth twice daily for four days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | Plaque score is 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) | 4 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark LeFelt, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research, Inc. | Paramus | New Jersey | 07652 | United States |
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Performed at the clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoride Toothpaste First | Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last |
| FG001 | Triclosan/Fluoride Toothpaste First | triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last |
| FG002 | Chlorhexidine Oral Rinse | chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention: |
| |||||||||||||
| Washout After 1st Intervention |
| |||||||||||||
| Second Intervention: |
| |||||||||||||
| Washout After 2nd Intervention |
| |||||||||||||
| Third Intervention: |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoride Toothpaste | negative control toothpaste |
| BG001 | Total Toothpaste | triclosan/fluoride toothpaste (positive control) |
| 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 score is 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) | Posted | Mean | Standard Deviation | Units on a scale | 4 Days |
|
2 month test period
subjects used the product twice a day for 4 days with oral exams at beginning and end of treatment periods.
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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 Toothpaste First | Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non related adverse event | Social circumstances | other | subject reported a fracture in a tooth while eating white bread. Subject had the tooth repair with a composite filling. Subject continued with study without interuption. Event determined to be not related to study toothpaste or rinse use. |
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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 |
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Triclosan, fluoride |
| Drug |
Brush twice daily |
|
|
| Chlorhexidine Gluconate | Drug | Rinse mouth twice a day |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Chlorhexidine Oral Rinse | chlorhexidine oral rinse (positive control) |
| 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 |
|
chlorhexidine oral rinse (positive control) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Triclosan/Fluoride Toothpaste First | triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last | 0 | 22 | 0 | 22 |
| EG002 | Chlorhexidine Oral Rinse | chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last | 0 | 22 | 1 | 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 |