Efficacy of Plaque Removal of a Novel Brushing Device

NCT05038293 | Completed Results FDA Device

• 1 other identifier: STUDY00013154
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Plaque

Keywords

Gingivitis; toothbrushing; oral hygiene; biofilm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush

  baseline, 1 minute after brushing

Study Arms (2)

Automated mouthpiece-based toothbrush

EXPERIMENTAL

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

Manual toothbrush

ACTIVE COMPARATOR

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

Interventions

Automated mouthpiece-based toothbrush DEVICE

One-time use during study visit.

Also known as: Novel toothbrushing device

Automated mouthpiece-based toothbrush

Manual toothbrush DEVICE

One-time use during study visit.

Manual toothbrush

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington, School of Dentistry, Regional Clinical Dental Research Center (RCDRC)

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Results Point of Contact

• Title: Dr. Diane Daubert
• Organization: University of Washington Department of Periodontics

ddaubert@uw.edu

206-685-3766

Study Officials

• Diane M Daubert, RDH, MS, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and the principal investigator will be blind to toothbrush device assignment. In order to maintain blinding and eliminate assessor bias, study team members instructing and observing participants in the use of the assigned toothbrushing device will not be outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor: School of Dentistry

Model Details: Single-blind, parallel group, randomized controlled clinical trial

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: September 9, 2021
• Study Start: September 17, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 31, 2023
• Results First Posted: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)