Dental Plaque, Gingivitis
Conditions
Brief summary
The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.
Interventions
Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (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 months (study duration).
DRUGfluoride only toothpaste
Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.
DRUGFluoride only mouthwash
Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.
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. Male and female subjects, ages 18-70, inclusive. 2. Availability for the six-month duration of the 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. Use of antibiotics 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. Pregnant women or women who are breast feeding. 9. Dental prophylaxis received in the past two weeks prior to baseline examinations. 10. History of allergies to oral care/personal care consumer products or their ingredients. 11. On any prescription medicines that might interfere with the study outcome. 12. An existing medical condition which prohibits eating or drinking for periods up to 4 hours. 13. History of alcohol or drug abuse
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
recruitment of subjects is done locally by the clinical site
Pre-assignment details
No washout or pre-assignment phase
Participants by arm
| Arm | Count |
|---|---|
| Toothpaste Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration). | 60 |
| Toothpaste + Mouthwash stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds. | 58 |
| Fluoride Only Toothpaste + Mouthwash Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds. | 61 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Toothpaste | Toothpaste + Mouthwash | Fluoride Only Toothpaste + Mouthwash | Total |
|---|---|---|---|---|
| Age, Continuous | 50.09 years STANDARD_DEVIATION 11.72 | 48.65 years STANDARD_DEVIATION 12.84 | 48.51 years STANDARD_DEVIATION 12.9 | 49.08 years STANDARD_DEVIATION 12.49 |
| Region of Enrollment United States | 60 participants | 58 participants | 61 participants | 179 participants |
| Sex: Female, Male Female | 47 Participants | 52 Participants | 47 Participants | 146 Participants |
| Sex: Female, Male Male | 13 Participants | 6 Participants | 14 Participants | 33 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 / 60 | 0 / 58 | 0 / 61 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 | 0 / 61 |
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 |
|---|---|---|---|
| Toothpaste | Dental Plaque Scores | 3.33 units on a scale | Standard Deviation 0.28 |
| Toothpaste + Mouthwash | Dental Plaque Scores | 3.22 units on a scale | Standard Deviation 0.27 |
| Fluoride Only Toothpaste + Mouthwash | Dental Plaque Scores | 3.34 units on a scale | Standard Deviation 0.26 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.04ANOVA
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: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste | Dental Plaque Scores | 2.26 units on a scale | Standard Deviation 0.23 |
| Toothpaste + Mouthwash | Dental Plaque Scores | 2.42 units on a scale | Standard Deviation 0.22 |
| Fluoride Only Toothpaste + Mouthwash | Dental Plaque Scores | 2.66 units on a scale | Standard Deviation 0.23 |
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 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste | Dental Plaque Scores | 1.84 units on a scale | Standard Deviation 0.25 |
| Toothpaste + Mouthwash | Dental Plaque Scores | 1.86 units on a scale | Standard Deviation 0.29 |
| Fluoride Only Toothpaste + Mouthwash | Dental Plaque Scores | 2.37 units on a scale | Standard Deviation 0.32 |
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 |
|---|---|---|---|
| Toothpaste | Gingivitis Scores | 2.18 units on a scale | Standard Deviation 0.16 |
| Toothpaste + Mouthwash | Gingivitis Scores | 2.17 units on a scale | Standard Deviation 0.22 |
| Fluoride Only Toothpaste + Mouthwash | Gingivitis Scores | 2.22 units on a scale | Standard Deviation 0.21 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.432ANOVA
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: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste | Gingivitis Scores | 1.48 units on a scale | Standard Deviation 0.15 |
| Toothpaste + Mouthwash | Gingivitis Scores | 1.65 units on a scale | Standard Deviation 0.16 |
| Fluoride Only Toothpaste + Mouthwash | Gingivitis Scores | 1.89 units on a scale | Standard Deviation 0.17 |
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 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste | Gingivitis Scores | 1.17 units on a scale | Standard Deviation 0.14 |
| Toothpaste + Mouthwash | Gingivitis Scores | 1.18 units on a scale | Standard Deviation 0.12 |
| Fluoride Only Toothpaste + Mouthwash | Gingivitis Scores | 1.85 units on a scale | Standard Deviation 0.13 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.001ANCOVA