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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapered bristles A | Experimental | Test toothbrush with tapered bristle |
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| Tapered bristles B | Active Comparator | Test toothbrush with tapered bristle |
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| End rounded bristles | Active Comparator | Conventionla toothbrush with end rounded bristle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapered bristles A | Device | Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week . |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline |
| 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. | Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria: Individuals may be included in the study if they meet all of the following inclusion criteria:
Exclusion Criteria: Individuals are not eligible for participation in this study if any of the following are noted:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin Garcia-Godoy, DDS, PhD | The University of Tennessee Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tapered Bristles A First, Tapered Bristle B Second, Then End Rounded Bristles | Participants were instructed to brush their teeth with test toothbrushes made with following bristles daily for two minutes, using only the provided toothpaste for one-week study period. One-week washout period separates each different intervention of one week. First intervention: Tapered bristles A Second intervention: Tapered bristles B Third inetervention: End rounded bristles |
| FG001 | Tapered Bristles B First, End Rounded Bristles Second, Then Tapered Bristles A | Participants were instructed to brush their teeth with test toothbrushes made with following bristles daily for two minutes, using only the provided toothpaste for one-week study period. One-week washout period separates each different intervention of one week. First intervention: Tapered bristles B Second intervention: End rounded bristles Third inetervention: Tapered bristles A |
| FG002 | End Rounded Bristles First, Tapered Bristles A Second, Then Tapered Bristles B | Participants were instructed to brush their teeth with test toothbrushes made with following bristles daily for two minutes, using only the provided toothpaste for one-week study period. One-week washout period separates each different intervention of one week. First intervention: End rounded bristles Second intervention: Tapered bristles A Third inetervention: Tapered bristles B |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
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| Washout (1 Week) |
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| Second Intervention (1 Week) |
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| Washout (1 Week) |
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| Third Intervention (1 Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Subject disposition for all arms |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline |
|
Up to 1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tapered Bristles A | Subjects use the toothbrush with Tapered bristles A two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mouth ulcer | Gastrointestinal disorders | Non-systematic Assessment |
Plaque area is not measured by image analysis due to: 1. The plaque area is so small as area% in a total region of interest. 2. 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Toru Saito | Sunstar Americas, Inc. | 1-847-794-4271 | toru.saito@us.sunstar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2020 | Jun 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| Tapered bristles B | Device | Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week. |
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| End rounded bristles | Device | Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week. |
|
| Pre-intervention at baseline and after 7- day brushing at baseline |
| 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. | Pre-intervention at baseline and after 7-day brushing at baseline |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Tapered Bristles B | Subjects use the toothbrush with Tapered bristles B two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week. |
| OG002 | End Rounded Bristles | Subjects use the toothbrush with End rounded bristles two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week. |
|
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| 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. | 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. | Posted | Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline |
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|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention at baseline and after 7- day brushing at baseline |
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|
|
| 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. | 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. | Posted | Pre-intervention at baseline and after 7-day brushing at baseline |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Tapered Bristles B | Subjects use the toothbrush with Tapered bristles B two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | End Rounded Bristles | Subjects use the toothbrush with End rounded bristles two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week. | 0 | 10 | 0 | 10 | 1 | 10 |
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| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
|