Efficacy of Plaque Removal of a Novel Brushing Device

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2022-02-01

Brief Summary

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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.

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Detailed Description

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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

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Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind, parallel group, randomized controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Automated mouthpiece-based toothbrush

Intervention Type DEVICE

One-time use during study visit.

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.

Group Type ACTIVE_COMPARATOR

Manual toothbrush

Intervention Type DEVICE

One-time use during study visit.

Interventions

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Automated mouthpiece-based toothbrush

One-time use during study visit.

Intervention Type DEVICE

Manual toothbrush

One-time use during study visit.

Intervention Type DEVICE

Other Intervention Names

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Novel toothbrushing device

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes