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.
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.
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:
- The toothbrush was placed at a 45-degree angle to the gum line.
- Each tooth was brushed using a gentle circular movement.
- The toothbrush was flicked down the tooth, away from the gum line.
- 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.
- 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):
- Put the brush inside the mouth, and bite on it slightly to be sure that all your teeth are inside it.
- 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.
- Conditions
- Full Mouth Plaque Score (FMPS)
- 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 group | Role | What they receive |
|---|---|---|
| Manual regular toothbrush | Experimental | Not described Receives: Device: Manual regular toothbrush |
| Autobrush U-shaped Toothbrush | Experimental | Not described Receives: Device: Autobrush U-shaped Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 Apr 2026
- Study start21 Dec 2023
- Primary completion27 Jan 2024
- Study completion27 Jan 2024
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahad Abudawood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shahad Abudawood, King Abdulaziz University
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
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 (U-shaped Toothbrush) Versus Manual Regular Toothbrush Among Children Aged From 9-12 Years
- ClinicalTrials.gov ID
- NCT07537803
- Acronym / sponsor ID
- 157-11-23
- Conditions
- Full Mouth Plaque Score (FMPS)
- Keywords
- Toothbrushing, Dental Plaque Index, Oral Hygiene, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shahad AbudawoodUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (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.
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.
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:
- The toothbrush was placed at a 45-degree angle to the gum line.
- Each tooth was brushed using a gentle circular movement.
- The toothbrush was flicked down the tooth, away from the gum line.
- 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.
- 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):
- Put the brush inside the mouth, and bite on it slightly to be sure that all your teeth are inside it.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual regular toothbrush | Experimental | Device: Manual regular toothbrush |
| Autobrush U-shaped Toothbrush | Experimental | Device: Autobrush U-shaped Toothbrush |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children
- Aged 9 to 12 years old
- Does not have fixed orthodontic treatment
- With Full Mouth Plaque Score (FMPS) of 30% or higher.
Key exclusion criteria (3 listed)
- Children with disabilities
- Children with oral appliances
- Children with nylon allergy.
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 |
|---|---|---|
| Manual regular toothbrushManual regular toothbrush | Device | Manual regular toothbrush |
| Autobrush U-shaped ToothbrushAutobrush U-shaped Toothbrush | Device | Autobrush U-shaped Toothbrush |
Primary outcome
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.
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. Patient privacy
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 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.