Trial Outcomes & Findings for Efficacy of Plaque Removal of a Novel Brushing Device (NCT NCT05038293)

Last Updated: 2023-03-31

Results Overview

Average Change from baseline plaque index after brushing with the automated mouthpiece-based brushing device versus a manual toothbrush. The Turesky Modification of the Quigley-Hein Plaque Index evaluates 6 areas per tooth and gives a score from 0-5 with 0 being no plaque and 5 being the highest amount of plaque and the average score for all sites was used for analysis.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

baseline,1 minute after brushing

Results posted on

2023-03-31

Participant Flow

subjects were recruited via flyers posted at the Center for Pediatric Dentistry at the University of Washington. If parents were interested they contacted the study coordinator for a phone screening.

62 parents called for a phone screening. Of those,48 subjects presented for the first appointment but 6 were not enrolled due to not meeting inclusion and exclusion criteria. 42 subjects were consented and enrolled.

Participant milestones

Participant milestones
Measure	Automated Mouthpiece-based Toothbrush Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink. Automated mouthpiece-based toothbrush: One-time use during study visit.	Manual Toothbrush Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water. Manual toothbrush: One-time use during study visit.
Overall Study STARTED	24	18
Overall Study COMPLETED	22	18
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Automated Mouthpiece-based Toothbrush Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink. Automated mouthpiece-based toothbrush: One-time use during study visit.	Manual Toothbrush Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water. Manual toothbrush: One-time use during study visit.
Overall Study device was not operating properly for one subject.	1	0
Overall Study one subject was dropped due to a behavioral issue	1	0

Baseline Characteristics

Efficacy of Plaque Removal of a Novel Brushing Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Automated Mouthpiece-based Toothbrush n=22 Participants Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink. Automated mouthpiece-based toothbrush: One-time use during study visit.	Manual Toothbrush n=18 Participants Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water. Manual toothbrush: One-time use during study visit.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.1 years n=5 Participants	10.8 years n=7 Participants	10.45 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	18 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline,1 minute after brushing

Population: participants aged 5-17 years

Outcome measures

Outcome measures
Measure	Automated Mouthpiece-based Toothbrush n=22 Participants Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink. Automated mouthpiece-based toothbrush: One-time use during study visit.	Manual Toothbrush n=18 Participants Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water. Manual toothbrush: One-time use during study visit.
Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index	0.29 units on a scale Interval 0.287 to 0.293	0.6 units on a scale Interval 0.578 to 0.628

SECONDARY outcome

Timeframe: baseline, 1 minute after brushing

Population: 5-17 year old subjects

Number of participants with soft tissue abrasion after brushing with the automated mouthpiece-based.brushing device versus a manual toothbrush. An intraoral soft tissue examination will be done before and after brushing and a binary scale will be used to note any areas of abrasion (yes or no). Outcome is the presence of any soft tissue abrasion that was not present prior to brushing.

Outcome measures

Outcome measures
Measure	Automated Mouthpiece-based Toothbrush n=22 Participants Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink. Automated mouthpiece-based toothbrush: One-time use during study visit.	Manual Toothbrush n=18 Participants Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water. Manual toothbrush: One-time use during study visit.
Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush	2 Participants	1 Participants

Adverse Events

Automated Mouthpiece-based Toothbrush

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Manual Toothbrush

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	Automated Mouthpiece-based Toothbrush n=22 participants at risk Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink. Automated mouthpiece-based toothbrush: One-time use during study visit.	Manual Toothbrush n=18 participants at risk Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water. Manual toothbrush: One-time use during study visit.
Skin and subcutaneous tissue disorders minor abrasion	9.1% 2/22 • Number of events 2 • baseline visit up to 1.5 hours. (study was one visit only) definition does not differ	5.6% 1/18 • Number of events 1 • baseline visit up to 1.5 hours. (study was one visit only) definition does not differ

Additional Information

Dr. Diane Daubert

University of Washington Department of Periodontics

Phone: 206-685-3766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place