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Full Mouth Plaque Score (FMPS)NCT07537803

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

A study testing Manual regular toothbrush and Autobrush U-shaped Toothbrush in people with Full Mouth Plaque Score (FMPS), run by Shahad Abudawood at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 9 to 12 years
Conditions the study is for
Full Mouth Plaque Score (FMPS)
What is being tested?
Manual regular toothbrush and Autobrush U-shaped Toothbrush
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSaudi Arabia
Study dates
21 Dec 2023to 27 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • King Abdulaziz University

    Jeddah

Other trials in Saudi Arabia

About this study

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.

Read the 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.

Being tested
Manual regular toothbrush, Autobrush U-shaped Toothbrush
Keywords
Toothbrushing, Dental Plaque Index, Oral Hygiene, Randomized Controlled Trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual regular toothbrushDevice

    Manual regular toothbrush

  • Autobrush U-shaped ToothbrushDevice

    Autobrush U-shaped Toothbrush

Study groups in NCT07537803
Study groupRoleWhat they receive
Manual regular toothbrushExperimentalNot described
Receives: Device: Manual regular toothbrush
Autobrush U-shaped ToothbrushExperimentalNot described
Receives: Device: Autobrush U-shaped Toothbrush

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Full Mouth Plaque Score

    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.

    Measured: At "Day 1" and "Day 14"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study start21 Dec 2023
  3. Primary completion27 Jan 2024
  4. Study completion27 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07537803
Sponsor's protocol ID
157-11-23
Status last verified
Apr 2026
First submitted
12 Apr 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patient privacy

Questions about this trial

What is this clinical trial studying?

A study testing Manual regular toothbrush and Autobrush U-shaped Toothbrush in people with Full Mouth Plaque Score (FMPS), run by Shahad Abudawood at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Full Mouth Plaque Score (time frame: At "Day 1" and "Day 14"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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