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Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.
This clinical research study was to train new examiners for short term plaque clinical methodologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride toothpaste | Placebo Comparator | Negative control |
|
| Triclosan/Fluoride toothpaste | Active Comparator | positive control toothpaste |
|
| Chlorhexidine Oral Rinse | Active Comparator | Positive Control mouthrinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Half mouth toothbrushing twice a day for four days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | Plaque 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) | Four days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Cronin, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Institutional Service Company | Northfield | New Jersey | 08225 | United States |
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Recruitment was performed by the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoride Toothpaste First | Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last |
| FG001 | Total Toothpaste First | triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last |
| FG002 | Chlorhexidine Oral Rinse First | chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period After 1st Intervention |
| |||||||||||||
| Second Intervention |
| |||||||||||||
| Washout After 2nd Intervention |
| |||||||||||||
| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoride Toothpaste | negative control |
| BG001 | Total Toothpaste | triclosan/fluoride toothpaste (positive control 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 | Plaque Index | Plaque 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) | per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods. | Posted | Mean | Standard Deviation | Units on a scale | Four days |
|
6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
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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 first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upset stomach - non related to product use | Social circumstances | Non-systematic Assessment | All events resolved in the same day to 3 days after reporting. Adverse events reported in this study were determined not to be related to study product 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 |
| C010882 | chlorhexidine gluconate |
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Chlorhexidine digluconate | Drug | Mouth rinsing with 15 ml for 30 seconds twice a day for four days. |
|
|
| Fluoride, triclosan | Drug | Half mouth Brushing twice daily |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
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| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Chlorhexidine Oral Rinse | chlorhexidine mouthrinse (positive control rinse) |
| 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 |
|
| OG002 | Chlorhexidine Oral Rinse | chlorhexidine mouthrinse (positive control rinse) |
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | Total Toothpaste First | triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last | 0 | 28 | 1 | 28 |
| EG002 | Chlorhexidine Oral Rinse First | chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last | 0 | 28 | 1 | 28 |
|
| Sinus headache - non related to product use | Social circumstances | Non-systematic Assessment | All events resolved in the same day to 3 days after reporting. Adverse events reported in this study were determined not to be related to study product use. |
|
| Menstrual cramps | Social circumstances | Non-systematic Assessment | All events resolved in the same day to 3 days after reporting. Adverse events reported in this study were determined not to be related to study product use. |
|
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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 |