Effectiveness of Autobrush® Versus Manual Toothbrush Among Adolescents With Fixed Orthodontic Appliances

April 20, 2026 updated by: Shahad Abudawood

Comparison of The Effectiveness of Autobrush® Versus Manual Regular Toothbrush Among Adolescents With Fixed Orthodontic Appliances

This study is a randomized crossover clinical trial designed to compare the effectiveness of a U-shaped automatic toothbrush (Autobrush®) versus a conventional manual toothbrush in reducing dental plaque among adolescents undergoing fixed orthodontic treatment. Each participant will be exposed to both interventions during the study period due to the crossover design.

The inclusion criteria included healthy adolescents aged 12-15 years, whom were undergoing treatment with fixed orthodontic appliances attending the Orthodontic Department at KAUD Medically compromised adolescents, those with disabilities, individuals without fixed orthodontic appliances, and adolescents with known nylon allergies were excluded.

Before appointment, participants were instructed to refrain from all oral hygiene measures (e.g., brushing, chewing gum) for 12 hours. On the appointment time, at the clinic, participants are assigned randomly to a toothbrush group and given disclosing solution to visualize plaque.

The FMPS was recorded before brushing. Then, participants brush under supervision with their assigned toothbrush group, either manual toothbrush using Bass technique for 2 minutes or using Autobrush® with side-to-side motion for 30 seconds. After brushing, FMPS is reassessed using the same disclosing procedure. Following a washout period of at least 2 weeks, the participant repeats the procedure with the alternative toothbrush.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King Abdulaziz University - Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy adolescents
  • Aged 12-15 years
  • With fixed orthodontic appliances
  • Attending the Orthodontic Department at KAUD

Exclusion Criteria:

  • Medically compromised adolescents, those with disabilities
  • Individuals without fixed orthodontic appliances
  • Adolescents with known nylon allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
This is a randomized crossover clinical trial design. Participants were randomly assigned to use the Autobrush® during the first phase. After a washout period, the groups switched to a manual toothbrush.
Device: Manual regular toothbrush
Manual regular toothbrush
Device: U-shaped toothbrush (Autobrush®)
U-shaped toothbrush (Autobrush®) was used
Experimental: Group 2
This is a randomized crossover clinical trial design. Participants were randomly assigned to use a manual toothbrush during the first phase. After a washout period, the groups switched to Autobrush® .
Device: Manual regular toothbrush
Manual regular toothbrush
Device: U-shaped toothbrush (Autobrush®)
U-shaped toothbrush (Autobrush®) was used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main outcome variable is the Full Mouth Plaque Score (FMPS)
Time Frame: 14 days

Plaque levels were recorded on six sites per tooth (three buccal and three lingual), both before and after brushing.

The FMPS difference is calculated as:

FMPS difference = FMPS before brushing - FMPS after brushing

This difference is expressed as a percentage:

(Number of sites with plaque / Total number of sites examined) × 100
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahad Abudawood

Collaborators

King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 153-11-24

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

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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