Clinical trial NCT05038293: Efficacy of Plaque Removal of a Novel Brushing Device
Official title: Efficacy of Plaque Removal of a Novel Brushing Device Compared to a Manual Toothbrush
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Keywords: Gingivitis
toothbrushing
oral hygiene
biofilm
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, parallel group, randomized controlled clinical trial
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: baseline,1 minute after brushing
Secondary outcomes:
measure: Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush
timeFrame: baseline, 1 minute after brushing
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, School of Dentistry, Regional Clinical Dental Research Center (RCDRC)
state: Washington
Study officials:
affiliation: University of Washington
name: Diane M Daubert, RDH, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: