Dental Plaque and Gingivitis
Conditions
Brief summary
This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.
Interventions
1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
DRUGActive Comparator
1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 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 period 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 that 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 |
|---|---|---|
| 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) |
| 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) |
Countries
Dominican Republic
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Toothpaste 1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study. | 55 |
| Experimental Toothpaste 1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study. | 54 |
| Active Comparator 1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study. | 53 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 4 |
Baseline characteristics
| Characteristic | Control Toothpaste | Experimental Toothpaste | Active Comparator | Total |
|---|---|---|---|---|
| Age, Continuous | 30.52 years STANDARD_DEVIATION 10.99 | 30.92 years STANDARD_DEVIATION 9.82 | 30.39 years STANDARD_DEVIATION 13.47 | 30.62 years STANDARD_DEVIATION 11.39 |
| Region of Enrollment Dominican Republic | 55 participants | 54 participants | 53 participants | 162 participants |
| Sex: Female, Male Female | 34 Participants | 31 Participants | 28 Participants | 93 Participants |
| Sex: Female, Male Male | 21 Participants | 23 Participants | 25 Participants | 69 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 / 55 | 0 / 54 | 0 / 53 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 | 0 / 53 |
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 |
|---|---|---|---|
| Control Toothpaste | Dental Plaque Scores | 2.91 units on a scale | Standard Deviation 0.24 |
| Experimental Toothpaste | Dental Plaque Scores | 2.95 units on a scale | Standard Deviation 0.29 |
| Active Comparator | Dental Plaque Scores | 2.90 units on a scale | Standard Deviation 0.2 |
Comparison: The null hypothesis states that there is no difference between groupsp-value: 0.571ANOVA
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 (from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Toothpaste | Dental Plaque Scores | 2.59 units on a scale | Standard Deviation 0.29 |
| Experimental Toothpaste | Dental Plaque Scores | 2.16 units on a scale | Standard Deviation 0.53 |
| Active Comparator | Dental Plaque Scores | 2.10 units on a scale | Standard Deviation 0.36 |
Comparison: The null hypothesis states that there is no difference between groupsp-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 (from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Toothpaste | Dental Plaque Scores | 2.47 units on a scale | Standard Deviation 0.42 |
| Experimental Toothpaste | Dental Plaque Scores | 1.82 units on a scale | Standard Deviation 0.45 |
| Active Comparator | Dental Plaque Scores | 1.75 units on a scale | Standard Deviation 0.39 |
Comparison: The null hypothesis states that there is no difference between groupsp-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 |
|---|---|---|---|
| Control Toothpaste | Gingivitis Scores | 1.48 units on a scale | Standard Deviation 0.23 |
| Experimental Toothpaste | Gingivitis Scores | 1.57 units on a scale | Standard Deviation 0.28 |
| Active Comparator | Gingivitis Scores | 1.49 units on a scale | Standard Deviation 0.2 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.091ANOVA
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 (from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Toothpaste | Gingivitis Scores | 1.46 units on a scale | Standard Deviation 0.19 |
| Experimental Toothpaste | Gingivitis Scores | 1.33 units on a scale | Standard Deviation 0.23 |
| Active Comparator | Gingivitis Scores | 1.25 units on a scale | Standard Deviation 0.18 |
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 (from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Toothpaste | Gingivitis Scores | 1.44 units on a scale | Standard Deviation 0.2 |
| Experimental Toothpaste | Gingivitis Scores | 1.23 units on a scale | Standard Deviation 0.23 |
| Active Comparator | Gingivitis Scores | 1.19 units on a scale | Standard Deviation 0.17 |
Comparison: The null hypothesis states that there is no difference between groupsp-value: <0.001ANCOVA