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The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Toothpaste | Active Comparator | Triclosan/Copolymer/fluoride toothpaste |
|
| Fluoride toothpaste | Placebo Comparator | sodium monofluorophosphate toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan/Copolymer/fluoride toothpaste | Drug | Twice daily usage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours | Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms) | 4 weeks |
| Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours | Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Paquette, DMD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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subjects were recruited by the PI at the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Toothpaste (Active) | triclosan/copolymer/fluoride toothpaste |
| FG001 | Colgate Great Regular Flavor (Placebo) | sodium monofluorophosphate toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Toothpaste (Active) | triclosan/copolymer/fluoride toothpaste |
| BG001 | Colgate Cavity Protection (Placebo) | sodium monofluorophosphate 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 | Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours | Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms) | Posted | Mean | Standard Deviation | Micrograms | 4 weeks |
|
|
29 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 | Total Toothpaste (Active) | triclosan/copolymer/fluoride toothpaste |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth Sensitivity to Cold | General disorders | Non-systematic Assessment | Subjects reported tooth sensitivity to cold |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Willliam DeVizio-DMD | Colgate Palmolive | 732-878-7901 | William_DeVizio@colpal.com |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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| sodium monofluorophosphate toothpaste | 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 |
|
| Participants |
|
|
|
| Primary | Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours | Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms) | Posted | Mean | Standard Deviation | Micrograms | 4 weeks |
|
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | Colgate Cavity Protection (Placebo) | sodium monofluorophosphate toothpaste | 0 | 25 | 6 | 25 |
|
| Oral irritation | General disorders | Non-systematic Assessment | subject reported oral irritation after using the study product |
|
| Cold and/or flu like symptoms | General disorders | Non-systematic Assessment | 2 subjects reported cold like symptoms halfway through the study and 1 subject reported flu like symptoms (Fever,chills and sore throat) at end of study. |
|
| pulled muscle | General disorders | Non-systematic Assessment | 1 subject reported a pulled muscle in their back at the end of the study |
|
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| D009057 |
| Stomatognathic Diseases |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |