CClinicalTrials.gg
CompletedNCT07537790Updated Apr 23, 2026

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

An interventional study of U-shaped toothbrush (Autobrush®) and Manual regular toothbrush in Full Mouth Plaque Score (FMPS), sponsored by Shahad Abudawood. Completed at 1 site in Saudi Arabia. Open to participants aged 12 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Shahad Abudawood · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years to 15 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Full Mouth Plaque Score (FMPS)

Keywords

  • Toothbrushing
  • Dental Plaque Index
  • Orthodontic Appliances
  • Adolescent
  • Oral Hygiene
  • Cross-Over Studies
  • Randomized Controlled Trial
03

In context

Lead sponsor

Shahad Abudawood is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Medically compromised adolescents, those with disabilities
  • Individuals without fixed orthodontic appliances
  • Adolescents with known nylon allergies
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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: U-shaped toothbrush (Autobrush®) · Device: Manual regular toothbrush

  • 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: U-shaped toothbrush (Autobrush®) · Device: Manual regular toothbrush

Interventions

  • DeviceU-shaped toothbrush (Autobrush®)

    U-shaped toothbrush (Autobrush®) was used

  • DeviceManual regular toothbrush

    Manual regular toothbrush

06

What researchers measure

Primary outcomes

  1. The main outcome variable is the Full Mouth Plaque Score (FMPS)

    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

    Time frame: 14 days

07

Study locations

1 site
  • King Abdulaziz University - Faculty of Dentistry
    Jeddah, Saudi Arabia
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 5, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07537790
Lead sponsor
Shahad Abudawood
Collaborators
King Abdulaziz University
Responsible party
Shahad Abudawood (Assistent peofessor, King Abdulaziz University) — Sponsor-investigator
First posted
Apr 17, 2026
Start date
Jan 1, 2025
Primary completion
Jan 1, 2026
Completion
Mar 1, 2026
Last update
Apr 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion