Gingivitis, Plaque, Dental
Conditions
Brief summary
The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods. This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.
Interventions
DEVICETapered bristles A
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
DEVICETapered bristles B
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
DEVICEEnd rounded bristles
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Sponsors
Sunstar Americas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Individuals may be included in the study if they meet all of the following inclusion criteria: * Must have read, understood and signed an informed consent prior to being entered into the study * Must be 18 to 70 years of age, male or female * Have at least 20 natural or restored teeth * Must have average Plaque Index of Ramfjord teeth at baseline greater than 2(Quigley and Hein) at screening * Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study * Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study * Agree to abstain from the use of any dental products other than those provided in the study * Agree to comply with the conditions and schedule of the study
Exclusion criteria
Individuals are not eligible for participation in this study if any of the following are noted: * Physical limitations or restrictions that might preclude normal tooth brushing * Evidence of gross oral pathology * Presence of severe gingivitis with 30 or more sites showing bleeding on probing * Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner * Chronic disease with concomitant oral manifestations * Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months * Currently using bleaching trays * Eating disorders * Recent history of substance abuse * Smoking \>10 cigarettes/day * Participation in other clinical studies within 14 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Navy Plaque Index (Navy Pl) After One-time Brushing | Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline | Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. Post-brushing value is calculated by averaging PI values of 10 subjects after a one-time brushing for 2 minutes |
| Change of Digitally Measured Interdental Plaque Area After One-time Brushing | Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline | Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after one-time brushing by image analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Navy Plaque Index (Navy PI) After 7-day Brushing | Pre-intervention at baseline and after 7- day brushing at baseline | Change of Navy Plaque Index (Navy Pl) after 7-day brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. 7-day value is calculated by averaging PI values of 10 subjects after 7-day brushing. |
| Change of Digitally Measured Interdental Plaque Area After 7-day Brushing | Pre-intervention at baseline and after 7-day brushing at baseline | Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after 7- day brushing by image analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Subject disposition for all arms | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change of Digitally Measured Interdental Plaque Area After One-time Brushing
Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after one-time brushing by image analysis.
Time frame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Population: No assessment was done due to: 1. The plaque area is so small as area % in a total region of interest. 2. Regardless of products, most of plaque on teeth surface of buccal side was removed after 2-minute brushing in most of subjects, so it is difficult to detect their difference. 3. Quality of accumulated plaque, e.g. thick but shallow area vs. thin but broad area, is hard to do the assessment. 4. Some photos were not appropriate for image analysis due to being a little out of focus.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change of Digitally Measured Interdental Plaque Area After One-time Brushing | Baseline | — |
| Unknown | Change of Digitally Measured Interdental Plaque Area After One-time Brushing | After one-time brushing for 2 minutes | — |
Primary
Change of Navy Plaque Index (Navy Pl) After One-time Brushing
Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. Post-brushing value is calculated by averaging PI values of 10 subjects after a one-time brushing for 2 minutes
Time frame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapered Bristles A | Change of Navy Plaque Index (Navy Pl) After One-time Brushing | After one-time brushing for 2 minutes | 145.4 score on a scale | Standard Deviation 61.8 |
| Tapered Bristles A | Change of Navy Plaque Index (Navy Pl) After One-time Brushing | Baseline | 367.5 score on a scale | Standard Deviation 67.4 |
| Tapered Bristles B | Change of Navy Plaque Index (Navy Pl) After One-time Brushing | After one-time brushing for 2 minutes | 123.8 score on a scale | Standard Deviation 59.6 |
| Tapered Bristles B | Change of Navy Plaque Index (Navy Pl) After One-time Brushing | Baseline | 346.5 score on a scale | Standard Deviation 70.4 |
| End Rounded Bristles | Change of Navy Plaque Index (Navy Pl) After One-time Brushing | After one-time brushing for 2 minutes | 130.1 score on a scale | Standard Deviation 59 |
| End Rounded Bristles | Change of Navy Plaque Index (Navy Pl) After One-time Brushing | Baseline | 355 score on a scale | Standard Deviation 50.9 |
Secondary
Change of Digitally Measured Interdental Plaque Area After 7-day Brushing
Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after 7- day brushing by image analysis.
Time frame: Pre-intervention at baseline and after 7-day brushing at baseline
Population: No assessment was done due to: 1. The plaque area is so small as area % in a total region of interest. 2. Regardless of products, most of plaque on teeth surface of buccal side was removed after 2-minute brushing in most of subjects, so it is difficult to detect their difference. 3. Quality of accumulated plaque, e.g. thick but shallow area vs. thin but broad area, is hard to do the assessment. 4. Some photos were not appropriate for image analysis due to being a little out of focus.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change of Digitally Measured Interdental Plaque Area After 7-day Brushing | Baseline | — |
| Unknown | Change of Digitally Measured Interdental Plaque Area After 7-day Brushing | 7 days | — |
Secondary
Change of Navy Plaque Index (Navy PI) After 7-day Brushing
Change of Navy Plaque Index (Navy Pl) after 7-day brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. 7-day value is calculated by averaging PI values of 10 subjects after 7-day brushing.
Time frame: Pre-intervention at baseline and after 7- day brushing at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapered Bristles A | Change of Navy Plaque Index (Navy PI) After 7-day Brushing | 7 days | 372.3 score on a scale | Standard Deviation 42.1 |
| Tapered Bristles A | Change of Navy Plaque Index (Navy PI) After 7-day Brushing | Baseline | 366.3 score on a scale | Standard Deviation 67.6 |
| Tapered Bristles B | Change of Navy Plaque Index (Navy PI) After 7-day Brushing | Baseline | 346.9 score on a scale | Standard Deviation 70.4 |
| Tapered Bristles B | Change of Navy Plaque Index (Navy PI) After 7-day Brushing | 7 days | 373.8 score on a scale | Standard Deviation 49.8 |
| End Rounded Bristles | Change of Navy Plaque Index (Navy PI) After 7-day Brushing | Baseline | 354.9 score on a scale | Standard Deviation 51.2 |
| End Rounded Bristles | Change of Navy Plaque Index (Navy PI) After 7-day Brushing | 7 days | 380.1 score on a scale | Standard Deviation 44.1 |