Efficacy of Plaque Removal of a Novel Brushing Device

University of Washington

Status: Completed

Conditions: Dental Plaque

Treatments: Device: Automated mouthpiece-based toothbrush; Device: Manual toothbrush

Study type: Interventional

Funder types: Other

Identifiers

NCT05038293

STUDY00013154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Automated mouthpiece-based toothbrush

Experimental group

Description:

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.

Treatment:

Device: Automated mouthpiece-based toothbrush

Manual toothbrush

Active Comparator group

Description:

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.

Treatment:

Device: Manual toothbrush