Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this clinical research study is to assess the efficacy of three oral hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a mouthwash in controlling established dental plaque and gingivitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1 | Active Comparator | triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash |
|
| Regimen 2 | Active Comparator | stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash |
|
| Regimen 3 - Control group | Placebo Comparator | fluoride toothpaste + fluoride Mouthwash |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash | Drug | Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Dental Plaque Scores | 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 Scores | 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) | 4 weeks |
| Dental Plaque Scores | 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 weeks |
| 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) | 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Comercial Plaza Trujillo | Trujillo Alto | 00976 | Puerto Rico |
There is no wash-out period prior to product randomization and distribution. Each subject was randomized and given a study treatment to follow after successfully completing the study screening procedures.
recruitment at clinical site
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Regimen 1 | triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 4 Week Product Use |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash | Drug | Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds. |
|
|
| fluoride toothpaste + fluoride Mouthwash | Drug | Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds. |
|
|
| 4 weeks |
| 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 weeks |
| FG001 |
| Regimen 2 |
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds. |
| FG002 | Regimen 3 - Control Group | fluoride toothpaste + fluoride Mouthwash fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 6 Week Product Use |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Regimen 1 | triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds. |
| BG001 | Regimen 2 | stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds. |
| BG002 | Regimen 3 - Control Group | fluoride toothpaste + fluoride Mouthwash fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds. |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 Scores | 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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Dental Plaque Scores | 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 | 4 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Dental Plaque Scores | 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 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 4 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 weeks |
|
6 weeks
Duration of study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regimen 1 | triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds. | 0 | 40 | 0 | 40 | ||
| EG001 | Regimen 2 | stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds. | 0 | 40 | 0 | 40 | ||
| EG002 | Regimen 3 - Control Group | fluoride toothpaste + fluoride Mouthwash fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds. | 0 | 40 | 0 | 40 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Devizio | Colgate Palmolive | 732-878-7901 | william_devizio@colpal.com |
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|
|
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|
|
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|
|
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|
|
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|
|