NCT05038293

Efficacy of Plaque Removal of a Novel Brushing Device

Efficacy of Plaque Removal of a Novel Brushing Device Compared to a Manual Toothbrush

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

Plaque is one of the main etiological factors in dental decay and the principal etiological factor for periodontal diseases. Although toothbrushes have greatly evolved, dexterity is still the key component to an efficient cleaning routine. The primary goal is to examine 60 participants to determine the efficacy of a new powered teeth cleaning device designed to bypass the variability of individual dexterity compared with manual toothbrushing. This is a single-blind, randomized controlled trial. Sixty pediatric patients will be recruited for the study and randomized into treatment and control groups, subdivided into primary (20), mixed (20), and permanent dentition (20). Participants will be asked to abstain from brushing, flossing, gum or mouthwash use for 24 hours prior to the study visit. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index before and after a one-time brushing with the assigned study device. A soft tissue assessment will be conducted and intraoral photos taken pre- and post-brushing.

Conditions

• Dental Plaque

Interventions

Type	Name	Description
DEVICE	Automated mouthpiece-based toothbrush	One-time use during study visit.
DEVICE	Manual toothbrush	One-time use during study visit.

Timeline

• Start date: 2021-09-17
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2021-09-09
• Last updated: 2023-03-31
• Results posted: 2023-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study