Full Mouth Plaque Score (FMPS)NCT07537790
Effectiveness of Autobrush® Versus Manual Toothbrush Among Adolescents With Fixed Orthodontic Appliances
A study testing U-shaped toothbrush (Autobrush®) and Manual regular toothbrush in people with Full Mouth Plaque Score (FMPS), run by Shahad Abudawood at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Full Mouth Plaque Score (FMPS)
- What is being tested?
- U-shaped toothbrush (Autobrush®) and Manual regular toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2025to 1 Mar 2026
- 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 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy adolescents
- Aged 12-15 years
- With fixed orthodontic appliances
- Attending the Orthodontic Department at KAUD
Who cannot join
- Medically compromised adolescents, those with disabilities
- Individuals without fixed orthodontic appliances
- Adolescents with known nylon allergies
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University - Faculty of Dentistry
Jeddah
About this study
Official title: 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.
Read more
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.
- Conditions
- Full Mouth Plaque Score (FMPS)
- Being tested
- U-shaped toothbrush (Autobrush®), Manual regular toothbrush
- Keywords
- Toothbrushing, Dental Plaque Index, Orthodontic Appliances, Adolescent, Oral Hygiene, Cross-Over Studies, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-shaped toothbrush (Autobrush®)Device
U-shaped toothbrush (Autobrush®) was used
Manual regular toothbrushDevice
Manual regular toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Device: U-shaped toothbrush (Autobrush®); Device: Manual regular toothbrush |
| Group 2 | Experimental | 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® . Receives: Device: U-shaped toothbrush (Autobrush®); Device: Manual regular toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Mouth Plaque Score (FMPS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahad Abudawood
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz University
- Responsible party
- Sponsor-investigator, Shahad Abudawood, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537790
- Sponsor's protocol ID
- 153-11-24
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effectiveness of Autobrush® Versus Manual Regular Toothbrush Among Adolescents With Fixed Orthodontic Appliances
- ClinicalTrials.gov ID
- NCT07537790
- Acronym / sponsor ID
- 153-11-24
- Conditions
- Full Mouth Plaque Score (FMPS)
- Keywords
- Toothbrushing, Dental Plaque Index, Orthodontic Appliances, Adolescent, Oral Hygiene, Cross-Over Studies, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shahad AbudawoodUniversity, hospital or other
- Collaborators
- King Abdulaziz University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: U-shaped toothbrush (Autobrush®), Device: Manual regular toothbrushThis 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. |
| Group 2 | Experimental | Device: U-shaped toothbrush (Autobrush®), Device: Manual regular toothbrushThis 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® . |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy adolescents
- Aged 12-15 years
- With fixed orthodontic appliances
- Attending the Orthodontic Department at KAUD
Key exclusion criteria (3 listed)
- Medically compromised adolescents, those with disabilities
- Individuals without fixed orthodontic appliances
- Adolescents with known nylon allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| U-shaped toothbrush (Autobrush®)U-shaped toothbrush (Autobrush®) was used | Device | Group 1, Group 2 |
| Manual regular toothbrushManual regular toothbrush | Device | Group 1, Group 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U-shaped toothbrush (Autobrush®) and Manual regular 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?
The main outcome variable is the Full Mouth Plaque Score (FMPS) (time frame: 14 days). 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.