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To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A- Positive Control | Active Comparator | fluoride/triclosan/copolymer toothpaste |
|
| B - Silica control | Placebo Comparator | fluoride only toothpaste |
|
| C- Experimental product | Experimental | fluoride/triclosan/amino acid toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan, Fluoride | Drug | Rinse 3 times daily with assigned toothpaste slurry |
|
| Measure | Description | Time Frame |
|---|---|---|
| ph of Dental Plaque After Sucrose Challenge | Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Imfeld, MBA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich, Dental Institute Dept. of Preventive | Zurich | Switzerland |
subjects are screened for medical and oral health criteria and start a 1 week washout period.
subjects are recruited by the PI at the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo 1st, Active Comparator 2nd and Experimental Last | Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days. |
| FG001 | Active Comparator 1st, Experimental 2nd and Placebo Last | Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days. |
| FG002 | Experimental 1st, Placebo 2nd and Active Comparator Last | Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Treatment Period |
| |||||||||||||
| Washout After 1st Treatment Period |
| |||||||||||||
| 2nd Treatment Period |
| |||||||||||||
| Washout After 2nd Treatment Period |
| |||||||||||||
| 3rd Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo First, Positive Control Second and Experimental Last | |
| BG001 | Positive Control First, Experimental Second and Placebo Last | |
| BG002 | Experimental First, Placebo Second and Positive Control Last |
| 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 | ph of Dental Plaque After Sucrose Challenge | Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth. | Posted | Mean | Standard Deviation | ph of dental plaque | 1 week |
|
6 weeks
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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 | Placebo First, Positive Control Second and Experimental Last |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William De Vizio | Colgate Palmolive Co. | 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 |
|---|---|
| D014260 | Triclosan |
| D005459 | Fluorides |
| C546060 | hydrated silica gel-based toothpaste |
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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| fluoride | Drug | Rinse 3 times daily with assigned toothpaste slurry |
|
|
| Fluoride, triclosan, amino acid | Drug | Rinse 3 times daily with assigned toothpaste slurry |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| NOT COMPLETED |
|
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Positive Control First, Experimental Second and Placebo Last | 0 | 2 | 0 | 2 |
| EG002 | Experimental First, Placebo Second and Positive Control Last | 0 | 2 | 0 | 2 |
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| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D000602 | Amino Acids, Peptides, and Proteins |