Trial Outcomes & Findings for Evaluation of Toothbrush Bristles in Plaque Reduction (NCT NCT04681885)

Last Updated: 2024-10-15

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline

Results posted on

2024-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
First Intervention (1 Week) STARTED	4	3	3
First Intervention (1 Week) COMPLETED	4	3	3
First Intervention (1 Week) NOT COMPLETED	0	0	0
Washout (1 Week) STARTED	4	3	3
Washout (1 Week) COMPLETED	4	3	3
Washout (1 Week) NOT COMPLETED	0	0	0
Second Intervention (1 Week) STARTED	4	3	3
Second Intervention (1 Week) COMPLETED	4	3	3
Second Intervention (1 Week) NOT COMPLETED	0	0	0
Third Intervention (1 Week) STARTED	4	3	3
Third Intervention (1 Week) COMPLETED	4	3	3
Third Intervention (1 Week) NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Toothbrush Bristles in Plaque Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=10 Participants Subject disposition for all arms
Age, Continuous	46 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline

Outcome measures

Outcome measures
Measure	Tapered Bristles A n=10 Participants Subjects use the toothbrush with Tapered bristles A two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method	Tapered Bristles B n=10 Participants 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.	End Rounded Bristles n=10 Participants 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.
Change of Navy Plaque Index (Navy Pl) After One-time Brushing Baseline	367.5 score on a scale Standard Deviation 67.4	346.5 score on a scale Standard Deviation 70.4	355 score on a scale Standard Deviation 50.9
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	123.8 score on a scale Standard Deviation 59.6	130.1 score on a scale Standard Deviation 59.0

PRIMARY outcome

Timeframe: 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.

Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after one-time brushing by image analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tapered Bristles A n=10 Participants Subjects use the toothbrush with Tapered bristles A two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method	Tapered Bristles B n=10 Participants 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.	End Rounded Bristles n=10 Participants 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.
Change of Navy Plaque Index (Navy PI) After 7-day Brushing Baseline	366.3 score on a scale Standard Deviation 67.6	346.9 score on a scale Standard Deviation 70.4	354.9 score on a scale Standard Deviation 51.2
Change of Navy Plaque Index (Navy PI) After 7-day Brushing 7 days	372.3 score on a scale Standard Deviation 42.1	373.8 score on a scale Standard Deviation 49.8	380.1 score on a scale Standard Deviation 44.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Tapered Bristles A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tapered Bristles B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

End Rounded Bristles

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tapered Bristles A n=10 participants at risk Subjects use the toothbrush with Tapered bristles A two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method	Tapered Bristles B n=10 participants at risk 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.	End Rounded Bristles n=10 participants at risk 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.
Gastrointestinal disorders Mouth ulcer	0.00% 0/10 • Up to 1 week	0.00% 0/10 • Up to 1 week	10.0% 1/10 • Number of events 1 • Up to 1 week

Additional Information

Toru Saito

Sunstar Americas, Inc.

Phone: 1-847-794-4271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60