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Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride Toothpaste | Placebo Comparator | fluoride control |
|
| Total/Whitening | Active Comparator | positive control |
|
| antibacterial plant extract 1 | Experimental | Honokiol |
|
| antibacterial plant extract 2 | Experimental | magnolol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Brush twice daily |
| |
| Triclosan/Fluoride toothpaste |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | Plaque score scale: Units on a 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) | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanfang Ren, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastman Dental Center - University of Rochester | Rochester | New York | 14642-8315 | United States |
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The dental clinic staff recruited for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoride Control, Magnolol,Total/Whitening,Honokiol | 1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol |
| FG001 | Total/Whitening, Honokiol, Fluoride Control, Magnolol | 1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol |
| FG002 | Honokiol, Fluoride Control, Magnolol, Total/Whitening | 1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control |
| FG003 | Magnolol, Total/Whitening, Honokiol, Fluoride Control | 1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Intervention |
| |||||||||||||
| 1 Week Washout After 1st Intervention |
| |||||||||||||
| 2nd Intervention |
| |||||||||||||
| 1 Week Washout After 2nd Intervention |
| |||||||||||||
| 3rd Intervention Order |
| |||||||||||||
| 1 Week Washout After 3rd Intervention |
| |||||||||||||
| 4th Intervention Order |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoride Control, Magnolol,Total/Whitening,Honokiol | 1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol |
| BG001 | Total/Whitening, Honokiol, Fluoride Control, Magnolol |
| 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 score scale: Units on a 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) | Posted | Mean | Standard Deviation | Units on a scale | 8 weeks |
|
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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 |
| D014260 | Triclosan |
| C005499 | honokiol |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Drug |
Brush twice daily |
|
| Fluoride | Drug | Brush twice daily |
|
|
| Fluoride | Drug | Brush twice daily |
|
| antibacterial plant extract | Other | Brush twice daily |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
| BG002 | Honokiol, Fluoride Control, Magnolol, Total/Whitening | 1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control |
| BG003 | Magnolol, Total/Whitening, Honokiol, Fluoride Control | 1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control |
| BG004 | 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 |
|
Fluoride/Honokiol extract toothpaste |
| OG003 | Herbal Extract Toothpaste | Fluoride/Magnolol extract toothpaste |
|
|
|
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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 |