Dental Plaque, Gingivitis
Conditions
Brief summary
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.
Interventions
0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
DRUGParodontax toothpaste
1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
Sponsors
Mahidol University
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-month duration ofthe 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 Score | 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
Thailand
Participant flow
Recruitment details
recruitment completed by the principal investigator at the clinical site.
Pre-assignment details
None. There is no wash out/pre-trial period for enrolled subjects. All accepted subjects were randomized upon study enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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 | 45 |
| 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 | 45 |
| Total | 135 |
Baseline characteristics
| Characteristic | Colgate Cavity Protection Toothpaste | Total | Parodontax | Colgate Total Toothpaste |
|---|---|---|---|---|
| Age, Continuous | 38.6 years | 38.48 years | 38.4 years | 38.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 45 Participants | 135 Participants | 45 Participants | 45 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Thailand | 45 participants | 135 participants | 45 participants | 45 participants |
| Sex: Female, Male Female | 24 Participants | 69 Participants | 23 Participants | 22 Participants |
| Sex: Female, Male Male | 21 Participants | 66 Participants | 22 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 | 0 / 45 |
Outcome results
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)
Time frame: 6 months post treatment use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Dental Plaque Score | 3.40 units on a scale | Standard Deviation 0.39 |
| Colgate Total Toothpaste | Dental Plaque Score | 1.65 units on a scale | Standard Deviation 0.45 |
| Parodontax | Dental Plaque Score | 3.23 units on a scale | Standard Deviation 0.35 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.p-value: 0.001ANCOVA
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)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Dental Plaque Score | 3.53 units on a scale | Standard Deviation 0.37 |
| Colgate Total Toothpaste | Dental Plaque Score | 3.55 units on a scale | Standard Deviation 0.36 |
| Parodontax | Dental Plaque Score | 3.59 units on a scale | Standard Deviation 0.36 |
Comparison: Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.p-value: 0.919ANOVA
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)
Time frame: 3 weeks post treatment use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Dental Plaque Score | 3.46 units on a scale | Standard Deviation 0.15 |
| Colgate Total Toothpaste | Dental Plaque Score | 2.98 units on a scale | Standard Deviation 0.37 |
| Parodontax | Dental Plaque Score | 3.50 units on a scale | Standard Deviation 0.25 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.p-value: 0.001ANCOVA
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)
Time frame: 3 months post treatment use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Dental Plaque Score | 3.31 units on a scale | Standard Deviation 0.42 |
| Colgate Total Toothpaste | Dental Plaque Score | 2.45 units on a scale | Standard Deviation 0.29 |
| Parodontax | Dental Plaque Score | 3.45 units on a scale | Standard Deviation 0.42 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.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 |
|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Gingivitis Scores | 1.77 units on a scale | Standard Deviation 0.15 |
| Colgate Total Toothpaste | Gingivitis Scores | 1.78 units on a scale | Standard Deviation 0.2 |
| Parodontax | Gingivitis Scores | 1.77 units on a scale | Standard Deviation 0.2 |
Comparison: Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.p-value: 0.922ANOVA
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 weeks post treatment use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Gingivitis Scores | 1.76 units on a scale | Standard Deviation 0.17 |
| Colgate Total Toothpaste | Gingivitis Scores | 1.65 units on a scale | Standard Deviation 0.23 |
| Parodontax | Gingivitis Scores | 1.67 units on a scale | Standard Deviation 0.21 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baselinep-value: 0.848ANCOVA
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 post treatment use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Gingivitis Scores | 1.63 units on a scale | Standard Deviation 0.32 |
| Colgate Total Toothpaste | Gingivitis Scores | 1.27 units on a scale | Standard Deviation 0.32 |
| Parodontax | Gingivitis Scores | 1.67 units on a scale | Standard Deviation 0.34 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.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 post treatment use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Gingivitis Scores | 1.57 units on a scale | Standard Deviation 0.28 |
| Colgate Total Toothpaste | Gingivitis Scores | 0.95 units on a scale | Standard Deviation 0.26 |
| Parodontax | Gingivitis Scores | 1.47 units on a scale | Standard Deviation 0.3 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.p-value: 0.001ANCOVA