Dental Plaque, Gingivitis
Conditions
Brief summary
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.
Interventions
DRUGtriclosan/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.
DRUGstannous 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.
DRUGfluoride 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.
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female subjects, ages 21-70, inclusive. 2. Availability for the six-week 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
Puerto Rico
Participant flow
Recruitment details
recruitment at clinical site
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| 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. | 40 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 4 Week Product Use | Lost to Follow-up | 1 | 1 | 1 |
| 6 Week Product Use | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Regimen 1 | Regimen 2 | Regimen 3 - Control Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 38 Participants | 39 Participants | 116 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 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 | 40 Participants | 40 Participants | 40 Participants | 120 Participants |
| Region of Enrollment United States | 40 participants | 40 participants | 40 participants | 120 participants |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 14 Participants | 47 Participants |
| Sex: Female, Male Male | 23 Participants | 24 Participants | 26 Participants | 73 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 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
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 |
|---|---|---|---|
| Regimen 1 | Dental Plaque Scores | 3.33 units on a scale | Standard Deviation 0.52 |
| Regimen 2 | Dental Plaque Scores | 3.19 units on a scale | Standard Deviation 0.53 |
| Regimen 3 - Control Group | Dental Plaque Scores | 3.31 units on a scale | Standard Deviation 0.48 |
Comparison: Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p\<0.5p-value: 0.434ANOVA
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 |
|---|---|---|---|
| Regimen 1 | Dental Plaque Scores | 2.78 units on a scale | Standard Deviation 0.56 |
| Regimen 2 | Dental Plaque Scores | 2.79 units on a scale | Standard Deviation 0.52 |
| Regimen 3 - Control Group | Dental Plaque Scores | 3.34 units on a scale | Standard Deviation 0.48 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P\<0.05p-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 |
|---|---|---|---|
| Regimen 1 | Dental Plaque Scores | 2.42 units on a scale | Standard Deviation 0.62 |
| Regimen 2 | Dental Plaque Scores | 2.59 units on a scale | Standard Deviation 0.58 |
| Regimen 3 - Control Group | Dental Plaque Scores | 3.38 units on a scale | Standard Deviation 0.49 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P\<0.05p-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 |
|---|---|---|---|
| Regimen 1 | Gingivitis Scores | 1.40 units on a scale | Standard Deviation 0.31 |
| Regimen 2 | Gingivitis Scores | 1.40 units on a scale | Standard Deviation 0.32 |
| Regimen 3 - Control Group | Gingivitis Scores | 1.44 units on a scale | Standard Deviation 0.37 |
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. Differences will be noted at P\<0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly differentp-value: 0.816ANOVA
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 |
|---|---|---|---|
| Regimen 1 | Gingivitis Scores | 1.19 units on a scale | Standard Deviation 0.23 |
| Regimen 2 | Gingivitis Scores | 1.30 units on a scale | Standard Deviation 0.27 |
| Regimen 3 - Control Group | Gingivitis Scores | 1.44 units on a scale | Standard Deviation 0.37 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05p-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 |
|---|---|---|---|
| Regimen 1 | Gingivitis Scores | 1.03 units on a scale | Standard Deviation 0.14 |
| Regimen 2 | Gingivitis Scores | 1.21 units on a scale | Standard Deviation 0.24 |
| Regimen 3 - Control Group | Gingivitis Scores | 1.46 units on a scale | Standard Deviation 0.36 |
Comparison: The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05p-value: <0.001ANCOVA