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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
10
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
The University of Tennessee Health Science Center
Memphis, Tennessee, United States
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
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
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
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
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