Efficacy of Plaque Removal of a Novel Brushing Device

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Device: Automated mouthpiece-based toothbrush; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington, School of Dentistry, Regional Clinical Dental Research Center (RCDRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Automated mouthpiece-based toothbrush; One-time use during study visit.; Other Names: Novel toothbrushing device
Active Comparator: 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.	Device: Manual toothbrush; One-time use during study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index	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.	baseline,1 minute after brushing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush	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.	baseline, 1 minute after brushing

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Diane M Daubert, RDH, MS, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: oral hygiene; biofilm; Gingivitis; toothbrushing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: STUDY00013154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No