Comparison of The Effectiveness of Autobrush (U-shaped Toothbrush) Versus Manual Regular Toothbrush Among Children Aged From 9-12 Years

April 20, 2026 updated by: Shahad Abudawood

Demographic information were collected from the participants. Assigned the participant to the intervention group. Participants were instructed to avoid all kinds of oral cleaning procedures approximately 12 hours before their appointments.

To assess the Full Mouth Plaque Score using a disclosing tablet.

participants were assigned to the Autobrush (U-shaped toothbrush) (Manual bundle with double-sided nylon brush head U-shaped fits 9-12 Years, San Diego, California).

First: Manual regular toothbrush (R):

Modified Bass Technique for the mixed dentition was used.

Second: Autobrush U-shaped Toothbrush (U) was used.

Subsequently, the examiner conducted a second FMPS examination.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study was discussed with the parents and participants after confirming the patient's eligibility, and the parents were asked to give their agreement. Demographic information from the participants was recorded and added to an Excel sheet. When the participants entered the clinics, they were asked to sit on the chair, and the brush to be used was placed in front of the patient according to the table of randomization, assigning the participant to the intervention group. Participants were instructed to avoid all kinds of oral cleaning procedures, including chewing gum, approximately 12 hours before their appointments. Text message reminders were sent the day before the appointment to remind them to stop all oral hygiene measures. To assess the Full Mouth Plaque Score, a disclosing tablet from (Produits Dentaires SA) was crushed using a sterile Porcelain Mortar to turn it into powder. The powder was then stored in a plastic jar and mixed with distilled water to create a disclosing solution. Regarding the randomization, 60 interventions were assigned: 30 participants were assigned to the manual regular toothbrush (Bamboo World Official, China), and the other 30 participants were assigned to the Autobrush (U-shaped toothbrush) (Manual bundle with double-sided nylon brush head U-shaped fits 9-12 Years, San Diego, California). Disposable paper cups were used by the first examiner to prepare two cups for each patient. In each cup, 1 measuring spoon of disclosing powder was added to 10 ml of distilled water using a measured plastic syringe, and the mixture was stirred together. Participants were asked to swish the solution for 30 seconds using a timer and then spit it out without rinsing. The first examiner then counted the stained teeth surfaces using the Full Mouth Plaque Score (FMPS) on 6 sites for each tooth, and the total number of teeth was recorded in the Excel sheet. Next, the second examiner taught each participant the right brushing technique based on the randomly selected toothbrush. A model and the assigned toothbrush were used for demonstration, and participants were instructed to brush twice a day. The following protocols were used for the brushing technique:

First: Manual regular toothbrush (R):

The Modified Bass Technique for the mixed dentition was used:

  1. The toothbrush was placed at a 45-degree angle to the gum line.
  2. Each tooth was brushed using a gentle circular movement.
  3. The toothbrush was flicked down the tooth, away from the gum line.
  4. The brushing sequence started from the buccal surface of Q1, Q2, Q3, and then Q4. Afterward, the lingual surface was brushed starting from Q4, Q3, Q2, and back to Q1.
  5. Brushing the occlusal surface for the upper and then the lower. The entire brushing time was 2 minutes, which was monitored using a timer in front of the participant.

Second: Autobrush U-shaped Toothbrush (U):

  1. Put the brush inside the mouth, and bite on it slightly to be sure that all your teeth are inside it.
  2. Sway left to right, be sure that the brush reached the maximum left and right for 2 minutes using a timer in front of the participant.

Every participant in the group was instructed to brush their teeth under supervision, without using toothpaste or rinsing with water. After brushing, the participant received the second cup of disclosing solution from the second examiner, who instructed them to swish for 30 seconds while timing themselves and then spit it out without washing. Subsequently, the initial examiner returned to the clinic to conduct a second FMPS examination, which was then documented on an Excel sheet. One of the examiners used fluoridated toothpaste and a regular toothbrush to clean the participant's discolored teeth of the pink stain before allowing them to leave. Finally, the participant was presented with the assigned toothbrush as a gift.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy children
  • Aged 9 to 12 years old
  • Does not have fixed orthodontic treatment
  • With Full Mouth Plaque Score (FMPS) of 30% or higher.

Exclusion Criteria:

  • Children with disabilities
  • Children with oral appliances
  • Children with nylon allergy.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Manual regular toothbrush
Device: Manual regular toothbrush
Manual regular toothbrush
Experimental: Autobrush U-shaped Toothbrush
Device: Autobrush U-shaped Toothbrush
Autobrush U-shaped Toothbrush

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Full Mouth Plaque Score
Time Frame: At "Day 1" and "Day 14"
Full Mouth Plaque Score (FMPS) was used to assess dental plaque accumulation, with scores ranging from 0% to 100%, where higher scores indicate greater plaque accumulation and therefore a worse oral hygiene outcome.
At "Day 1" and "Day 14"

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shahad Abudawood

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 157-11-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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Conditions

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