Gingival Inflammation
Conditions
Keywords
Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Consumer Satisfaction
Brief summary
Objectives: To assess the change in gingival index (GI) and plaque index (PI) when comparing the use of toothpaste tablets to conventional toothpaste. Methods: 40 participants were randomized into two groups: Colgate's toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (C). Both groups utilized their assigned dentifrice for 2 weeks. A pre and post-assessment measured the GI and PI index. A questionnaire on the use of the product was distributed.
Interventions
Colgate Anywhere Toothpaste Tablets
Colgate Cavity Protection
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Investigator blinded to group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects are 18 years or older; 2. Subjects who will comply with study protocol; 3. Subjects who can read and understand the consent form; 4. Subjects available during the study period; 5. Subjects have more than 20 teeth.
Exclusion criteria
1. Subjects who are pregnant and/or nursing; 2. Subjects under the age of 18.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index Score at Baseline | Change between baseline at visit 1 and visit 2, two weeks post baseline. | Plaque was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0: No plaque. 1. Separate flecks of plaque at the cervical margin. 2. A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin. 3. A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth. 4. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. 5. Plaque covering 2/3 or more of the side of the crown of the tooth. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth. |
| Gingival Index Score at Baseline | Change between baseline at visit 1 and visit 2, two weeks post baseline. | Gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation. 1. = Mild inflammation-slight change in color and little change in texture. 2. = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy. 3. = Severe inflammation-marked redness and hypertrophy. Tendency for spontaneous bleeding. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Perception of Product Use | Visit 2 two weeks post study enrollment | This is a composite measurement based on questionnaire response. Subjects will answer 7 questions related to cleanliness, flavor, ease of use, eco-friendliness, willingness to switch, satisfaction, texture. This is measured on a Likert Scale from 1-4. 1 represents strongly agree with overall product satisfaction. 4 represents strongly disagree with overall product satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Toothpaste Tablet Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes.
Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets | 20 |
| Conventional Toothpaste Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes.
Conventional Toothpaste: Colgate Cavity Protection | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Conventional Toothpaste | Total | Toothpaste Tablet |
|---|---|---|---|
| Age, Continuous | 25.35 years STANDARD_DEVIATION 4.15 | 25.15 years STANDARD_DEVIATION 4.12 | 24.95 years STANDARD_DEVIATION 4.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 12 Participants | 26 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Gingival Index Score at Baseline
Gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation. 1. = Mild inflammation-slight change in color and little change in texture. 2. = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy. 3. = Severe inflammation-marked redness and hypertrophy. Tendency for spontaneous bleeding. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
Time frame: Change between baseline at visit 1 and visit 2, two weeks post baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Tablet | Gingival Index Score at Baseline | 1.35 Score on a scale | Standard Deviation 0.26 |
| Conventional Toothpaste | Gingival Index Score at Baseline | 1.37 Score on a scale | Standard Deviation 0.24 |
Primary
Plaque Index Score at Baseline
Plaque was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0: No plaque. 1. Separate flecks of plaque at the cervical margin. 2. A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin. 3. A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth. 4. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. 5. Plaque covering 2/3 or more of the side of the crown of the tooth. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
Time frame: Change between baseline at visit 1 and visit 2, two weeks post baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Tablet | Plaque Index Score at Baseline | 2.80 Score on a scale | Standard Deviation 0.58 |
| Conventional Toothpaste | Plaque Index Score at Baseline | 2.78 Score on a scale | Standard Deviation 0.46 |
Secondary
Subject Perception of Product Use
This is a composite measurement based on questionnaire response. Subjects will answer 7 questions related to cleanliness, flavor, ease of use, eco-friendliness, willingness to switch, satisfaction, texture. This is measured on a Likert Scale from 1-4. 1 represents strongly agree with overall product satisfaction. 4 represents strongly disagree with overall product satisfaction.
Time frame: Visit 2 two weeks post study enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Tablet | Subject Perception of Product Use | 2.0 units on a scale | Standard Deviation 0.4 |
| Conventional Toothpaste | Subject Perception of Product Use | 1.7 units on a scale | Standard Deviation 0.4 |