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Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total toothpaste | Experimental | Triclosan/copolymer/fluoride toothpaste |
|
| Ultrabrite toothpaste | Placebo Comparator | Fluoride Toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan and Fluoride | Drug | Brush twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on Probing | Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored. | 6 months |
| Mean Pocket Depth | Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth. | 6 Months |
| Mean Percentage of Plaque Scores | Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Ramberg, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ariminum Research & Dental Education Center | Rimini | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Toothpaste | Triclosan/copolymer/Fluoride |
| FG001 | Ultrabrite Toothpaste | sodium fluoride control(placebo) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Toothpaste | Triclosan/copolymer/Fluoride |
| BG001 | Ultrabrite Toothpaste | sodium fluoride control (placebo) |
| 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 | Bleeding on Probing | Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored. | Posted | Mean | Standard Deviation | Percentage of bleeding sites | 6 months |
|
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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 | Triclosan/copolymer/Fluoride |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William De Vizio, DMD | Colgate Palmolive Co | 732-878-7901 | William_Devizio@colpal.com |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014260 | Triclosan |
| D005459 | Fluorides |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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| Fluoride | Drug | Brush twice daily |
|
|
| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Mean Pocket Depth | Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth. | Posted | Mean | Standard Deviation | Millimeters | 6 Months |
|
|
|
|
| Primary | Mean Percentage of Plaque Scores | Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored. | Posted | Mean | Standard Deviation | percentage of dental plaque | 6 Months |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Ultrabrite Toothpaste | sodium fluoride control (placebo) | 0 | 29 | 0 | 29 |
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| D009057 |
| Stomatognathic Diseases |
| 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 |