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The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.
The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Active Comparator |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Brush twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental Plaque Index | Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth) | 4-Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Van Dyke, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University School of Dental Medicine | Boston | Massachusetts | 02118 | United States |
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At clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoride | |
| FG001 | Fluoride/Triclosan | |
| FG002 | Chlorhexidine Gluconate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoride | |
| BG001 | Fluoride/Triclosan | |
| BG002 | Chlorhexidine Gluconate |
| 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 | Dental Plaque Index | Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth) | Posted | Mean | Standard Deviation | Units on a scale | 4-Day |
|
|
4 day treatment period
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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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Canker sore | General disorders | Non-systematic Assessment | Aphtous lesion (canker sore) reported by patient. Patient history determined that canker sores occur after eating spicy food. Sore abated without treatment. Relationship to study product use doubtful. |
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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 |
|---|---|
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005459 | Fluorides |
| C012980 | fluorophosphate |
| D014260 | Triclosan |
| D012969 | Sodium Fluoride |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Triclosan/Fluoride | Drug | Half mouth toothbrushing twice daily for 4 days |
|
|
| Chlorhexidine Gluconate | Drug | Mouth rinsing twice a day for 4 days |
|
|
| 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 |
|
|
|
|
| 0 |
| 9 |
| 6 |
| 9 |
| EG001 | Fluoride/Triclosan | 0 | 8 | 1 | 8 |
| EG002 | Chlorhexidine Gluconate | 0 | 8 | 0 | 8 |
|
| Cold symptoms | General disorders | Non-systematic Assessment | patient reported feeling cold symptoms. Events noted before treatment period started. Patients were on washout toothpaste (fluoride toothpaste). Relationship to study product use doubtful. |
|
| Conjunctivitis | General disorders | Non-systematic Assessment | Patient reported conjuctivitis and was treated with antibiotics. Event occurred during the washout period (fluoride toothpaste) and abated after antibiotic use. Relationship to product use doubtful. |
|
| Heavy menstrual bleeding | General disorders | Non-systematic Assessment | Patient reported heavy menstrual bleeding and took OTC medication and vitamins on her own. Symptoms abated after 2 days. Relationship to product use doubtful. |
|
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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 |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |