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| Name | Class |
|---|---|
| Mahidol University | OTHER |
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The objective of this randomized, single center, parallel clinical research study is to evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste, Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and dental plaque in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colgate Cavity Protection toothpaste | Placebo Comparator | Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland |
|
| Colgate Total toothpaste | Active Comparator | Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland |
|
| Parodontax | Active Comparator | Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate Cavity Protection toothpaste | Drug | 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental Plaque Score | Dental Plaque (Quigley-Hein, Turesky Modification Index) 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) | baseline |
| Dental Plaque Score | Dental Plaque (Quigley-Hein, Turesky Modification Index) 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) | 3 weeks post treatment use |
| Dental Plaque Score | Dental Plaque (Quigley-Hein, Turesky Modification Index) 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) | 3 months post treatment use |
| Dental Plaque Score | Dental Plaque (Quigley-Hein, Turesky Modification Index) 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) | 6 months post treatment use |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terdphong Triratana | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahidol University | Ratchathewi | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26087570 | Derived | Triratana T, Kraivaphan P, Amornchat C, Mateo LR, Morrison BM Jr, Dibart S, Zhang YP. Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study. Am J Dent. 2015 Apr;28(2):68-74. |
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None. There is no wash out/pre-trial period for enrolled subjects. All accepted subjects were randomized upon study enrollment.
recruitment completed by the principal investigator at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colgate Cavity Protection Toothpaste | Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment. |
| FG001 | Colgate Total Toothpaste | Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste |
| FG002 | Parodontax | Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland. Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colgate Cavity Protection Toothpaste | Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Score | Dental Plaque (Quigley-Hein, Turesky Modification Index) 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 | baseline |
|
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 | Colgate Cavity Protection Toothpaste | Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Ryan | Colgate Palmolive Company | 732-878-7766 | maria_ryan@colpal.com |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C546060 | hydrated silica gel-based toothpaste |
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| Colgate Total toothpaste | Drug | 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste |
|
| Parodontax toothpaste | Drug | 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste |
|
| baseline |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 3 weeks post treatment use |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 3 months post treatment use |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 6 months post treatment use |
| Colgate Total Toothpaste |
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste |
| BG002 | Parodontax | Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland. Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste |
| OG002 | Parodontax | Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland. Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste |
|
|
|
| Primary | Dental Plaque Score | Dental Plaque (Quigley-Hein, Turesky Modification Index) 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 | 3 weeks post treatment use |
|
|
|
|
| Primary | Dental Plaque Score | Dental Plaque (Quigley-Hein, Turesky Modification Index) 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 | 3 months post treatment use |
|
|
|
|
| Primary | Dental Plaque Score | Dental Plaque (Quigley-Hein, Turesky Modification Index) 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 | 6 months post treatment use |
|
|
|
|
| Primary | Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
|
| Primary | Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | Posted | Mean | Standard Deviation | units on a scale | 3 weeks post treatment use |
|
|
|
|
| Primary | Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | Posted | Mean | Standard Deviation | units on a scale | 3 months post treatment use |
|
|
|
|
| Primary | Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | Posted | Mean | Standard Deviation | units on a scale | 6 months post treatment use |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Colgate Total Toothpaste | Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste | 0 | 45 | 0 | 45 | 0 | 45 |
| EG002 | Parodontax | Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland. Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste | 0 | 45 | 0 | 45 | 0 | 45 |
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| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |