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Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | fluoride toothpaste control |
|
| B | Active Comparator | triclosan/fluoride toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Whole mouth brushing for 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| CFU (Colony Forming Units) | Total number of salivary bacterial colony forming units (lower number = less colonies present) | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neelim Utgikar, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| India GTC, Colgate Palmolive(I) ltd | Mumbai | India |
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At clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoride 1st , Triclosan/Fluoride 2nd | Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period. |
| FG001 | Triclosan/Fluoride 1st, Fluoride 2nd | Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout After 1st Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoride 1st, Triclosan/Fluoride 2nd | Fluoride toothpaste (placebo) |
| BG001 | Triclosan/Fluoride 1st, Fluoride 2nd | Triclosan/Fluoride toothpaste (experimental) |
| 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 | CFU (Colony Forming Units) | Total number of salivary bacterial colony forming units (lower number = less colonies present) | Posted | Mean | Standard Deviation | number of colony forming units | 4 hours |
|
|
16 days
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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 1st , Triclosan/Fluoride 2nd | Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period. |
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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 |
|---|---|
| D005459 | Fluorides |
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Triclosan/Fluoride | Drug | Brush whole mouth twice daily for 7 days |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| 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 |
|
| Participants |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Triclosan/Fluoride 1st, Fluoride 2nd | Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period. | 0 | 22 | 0 | 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 |