N/A N=42 Randomized Double-blind Treatment

Efficacy of Plaque Removal of a Novel Brushing Device

Dental Plaque

Bottom Line

View on ClinicalTrials.gov: NCT05038293 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index — 0.29; 0.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Automated mouthpiece-based toothbrush (Device); Manual toothbrush (Device)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index	0.29; 0.6	—
SECONDARY Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush	2; 1	—

Summary

The purpose of this research study is to compare how a novel, automated mouthpiece-based toothbrushing device removes dental plaque compared to a manual toothbrush.

Eligibility Criteria

Inclusion Criteria

Between the ages of 5-17
In good general health
Fluent in English
Parent or guardian willing and able to provide written informed consent
Have 16 scorable teeth (non-crown/bridge/or full amalgams)
Have had a dental cleaning and exam in the past 24 months

Exclusion Criteria

Advanced periodontal disease or severe gum disease
Mouth or teeth pain that prevents brushing in any areas
Intraoral piercings (tongue or lip) that cannot be removed
Non-controlled diabetes
Any autoimmune or infectious disease or any medical condition that would delay wound healing
Untreated visible cavities or untreated dental work
Oral or gum surgery in the previous 2 months
Take antibiotic premedication for dental procedures
Undergoing or require extensive dental or orthodontic treatment
Current smoker
Generalized recession over 1mm

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05038293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.