Dental Plaque, Gingivitis
Conditions
Brief summary
The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.
Interventions
Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).
Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).
DRUGfluoride toothpaste
Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).
Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.
Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects, ages 18-70, inclusive. 2. Availability for the six-week duration of the clinical research study. 3. Good general health. 4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. 6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification). 7. Signed Informed Consent Form
Exclusion criteria
1. Presence of orthodontic bands. 2. Presence of partial removable dentures. 3. Tumor(s) of the soft or hard tissues of the oral cavity. 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 5. Five or more carious lesions requiring immediate restorative treatment. 6. Antibiotic use any time during the one month prior to entry into the study. 7. Participation in any other clinical study or test panel within the one month prior to entry into the study. 8. Dental prophylaxis during the past two weeks prior to baseline examinations. 9. History of allergies to oral care/personal care consumer products or their ingredients. 10. On any prescription medicines that might interfere with the study outcome. 11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours. 12. History of alcohol or drug abuse. 13. Pregnant or lactating subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Plaque Scores | Baseline | 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) |
| Gingivitis Scores | Baseline | 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) |
Countries
United States
Participant flow
Recruitment details
Subject recruitment is completed locally by the clinical site
Pre-assignment details
There is no wash out or pre-assignment of any study product.
Participants by arm
| Arm | Count |
|---|---|
| Total Toothpaste Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration). | 43 |
| Toothpaste + Mouthwash Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time. | 43 |
| Control Group fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time. | 43 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total Toothpaste | Toothpaste + Mouthwash | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 44.68 years STANDARD_DEVIATION 16.85 | 44.90 years STANDARD_DEVIATION 15.51 | 44.39 years STANDARD_DEVIATION 13.68 | 44.47 years STANDARD_DEVIATION 15.26 |
| Region of Enrollment United States | 43 participants | 43 participants | 43 participants | 129 participants |
| Sex: Female, Male Female | 23 Participants | 25 Participants | 24 Participants | 72 Participants |
| Sex: Female, Male Male | 20 Participants | 18 Participants | 19 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 | 0 / 43 |
Outcome results
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Dental Plaque Scores | 3.91 units on a scale | Standard Deviation 0.31 |
| Toothpaste + Mouthwash | Dental Plaque Scores | 3.86 units on a scale | Standard Deviation 0.45 |
| Control Group | Dental Plaque Scores | 3.84 units on a scale | Standard Deviation 0.23 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.652ANOVA
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)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Dental Plaque Scores | 3.42 units on a scale | Standard Error 0.06 |
| Toothpaste + Mouthwash | Dental Plaque Scores | 3.69 units on a scale | Standard Error 0.06 |
| Control Group | Dental Plaque Scores | 3.73 units on a scale | Standard Error 0.06 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.001ANCOVA
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)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Dental Plaque Scores | 1.05 units on a scale | Standard Error 0.04 |
| Toothpaste + Mouthwash | Dental Plaque Scores | 1.15 units on a scale | Standard Error 0.04 |
| Control Group | Dental Plaque Scores | 1.24 units on a scale | Standard Error 0.04 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.001ANCOVA
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Gingivitis Scores | 1.38 units on a scale | Standard Deviation 0.22 |
| Toothpaste + Mouthwash | Gingivitis Scores | 1.35 units on a scale | Standard Deviation 0.24 |
| Control Group | Gingivitis Scores | 1.41 units on a scale | Standard Deviation 0.24 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.533ANOVA
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)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Gingivitis Scores | 1.15 units on a scale | Standard Error 0.04 |
| Toothpaste + Mouthwash | Gingivitis Scores | 1.20 units on a scale | Standard Error 0.04 |
| Control Group | Gingivitis Scores | 1.30 units on a scale | Standard Error 0.04 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.001ANCOVA
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)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Gingivitis Scores | 1.05 units on a scale | Standard Error 0.04 |
| Toothpaste + Mouthwash | Gingivitis Scores | 1.15 units on a scale | Standard Error 0.04 |
| Control Group | Gingivitis Scores | 1.24 units on a scale | Standard Error 0.04 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.001ANCOVA