Autism Spectrum DisorderNCT07160517
AI Toothbrush and Visual Pedagogy to Improve Oral Hygiene in Children With Autism Spectrum Disorder
A study testing Visual Pedagogy and Manual Toothbrushing in people with Autism Spectrum Disorder and Child, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This randomized clinical trial evaluates the effectiveness of an AI-enabled electric toothbrush and visual pedagogy materials in improving oral hygiene among children with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Child, Oral Health
- What is being tested?
- Visual Pedagogy and Manual Toothbrushing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2025to 10 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria:Children aged 5-13 years with a prior diagnosis of autism spectrum disorder (ASD) level 1 , 2 or 3 confirmed by a neuropediatrician.
Child must be accompanied by a primary caregiver (≥18 years old) responsible for daily oral hygiene.
Caregiver must have access to a smartphone or computer to interact with the digital platform.
Written informed consent (TCLE) from the caregiver and assent (TALE) from the child.
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Exclusion Criteria:Severe systemic medical conditions that contraindicate participation in clinical oral evaluations.
Children with advanced periodontal disease or other oral conditions requiring urgent dental treatment.
Caregivers who are unable or unwilling to use basic digital platforms (smartphone, tablet, or computer).
Families who decline participation at any stage of the study.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andiara De Rossi, DDS, PhD contact
Marilia Goulardins Gomes, DDS, MSc contact
Brazil1 site
School of Dentistry of Ribeirão Preto - University of São Paulo (FORP-USP)
Ribeirão Preto, São Paulo, 14040907
About this study
Official title: Effectiveness of an Artificial Intelligence-Enabled Electric Toothbrush and Visual Pedagogy Materials on Oral Hygiene of Children With Autism Spectrum Disorder
This randomized clinical trial evaluates the effectiveness of an AI-enabled electric toothbrush and visual pedagogy materials in improving oral hygiene among children with autism spectrum disorder (ASD). The study compares plaque control, gingival health, and adherence between children using a manual toothbrush with visual pedagogy support and those using an AI-enabled electric toothbrush with app-based monitoring.
Read the detailed description
: Children with autism spectrum disorder (ASD) often face behavioral, motor, and sensory challenges that compromise their ability to perform effective toothbrushing. Caregivers are typically responsible for daily oral hygiene, yet few accessible digital or AI-based tools exist to support this process.
This study addresses this gap by combining two innovative approaches: visual pedagogy resources (picture exchange communication cards and tactile sensory panels) and an AI-enabled electric toothbrush with app-based monitoring. A randomized, parallel clinical trial will be conducted at the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP-USP), including 60 children aged 6-12 years with ASD. Participants will be randomized into two groups:
- Group 1: Manual toothbrushing with caregiver support and visual pedagogy materials.
- Group 2: AI-enabled electric toothbrush (Oral-B Genius X) with app-based feedback monitoring brushing time, pressure, and sequence.
- Conditions
- Autism Spectrum Disorder, Child, Oral Health, Artificial Intelligence
- Being tested
- Visual Pedagogy and Manual Toothbrushing
- Keywords
- Autism Spectrum Disorder, Toothbrushing, Oral Hygiene, Artificial Intelligence.
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Pedagogy and Manual ToothbrushingBehavioural
Also called Visual support materials, Picture Exchange Communication System (PECS), tactile sensory panels
Participants in this arm will use a manual toothbrush with caregiver support. Visual pedagogy resources will include printed PECS cards illustrating each step of toothbrushing and tactile sensory panels simulating toothbrush bristles, toothpaste texture, and dental floss. Caregivers will be instructed to use these materials daily at home for 3 weeks to improve comprehension, adherence, and cooperation in children with ASD.
| Study group | Role | What they receive |
|---|---|---|
| Manual Toothbrushing + Visual Pedagogy | Active comparator | Participants will use a manual toothbrush with caregiver support. Visual pedagogy materials will be provided, including printed picture exchange communication system (PECS) cards illustrating each step of toothbrushing and tactile sensory panels simulating toothbrush bristles, toothpaste texture, and dental floss. Caregivers will be instructed to use these materials daily to improve comprehension and adherence to toothbrushing routines. Receives: Behavioral: Visual Pedagogy and Manual Toothbrushing |
| AI-enabled Electric Toothbrush | Experimental | Participants will use an Oral-B Genius X electric toothbrush equipped with artificial intelligence and Bluetooth connectivity. The device monitors brushing time, sequence, and pressure, providing real-time feedback through a smartphone application. Caregivers will be trained to supervise and encourage daily use at home for 3 weeks. The intervention aims to improve plaque removal and promote autonomy and motivation during oral hygiene in children with ASD. Receives: Behavioral: Visual Pedagogy and Manual Toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index (Simplified Oral Hygiene Index - Greene & Vermillion)
Difference in gingival health between baseline and follow-up, assessed using the Löe and Silness Gingival Index. Higher scores indicate worse gingival condition.
Measured: Baseline, Week 3, Week 6
Secondary outcomes (1)
Bleeding on Probing (Community Periodontal Index)
Assessment of bleeding on probing at six index teeth sites, following WHO Community Periodontal Index criteria.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- participants are randomized into two parallel arms: manual toothbrushing with visual pedagogy vs. AI-enabled electric toothbrush.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marília Goulardins, University of Sao Paulo
- Investigators
- Paulo Nelson Filho, DDS, PhD, Study director, Full Professor, Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto - USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160517
- Sponsor's protocol ID
- CAAE80167324500005419
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Artificial Intelligence-Enabled Electric Toothbrush and Visual Pedagogy Materials on Oral Hygiene of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07160517
- Acronym / sponsor ID
- CAAE80167324500005419
- Conditions
- Autism Spectrum Disorder, Child, Oral Health, Artificial Intelligence
- Keywords
- Autism Spectrum Disorder, Toothbrushing, Oral Hygiene, Artificial Intelligence.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 8 Sep 2025 (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 randomized clinical trial evaluates the effectiveness of an AI-enabled electric toothbrush and visual pedagogy materials in improving oral hygiene among children with autism spectrum disorder (ASD). The study compares plaque control, gingival health, and adherence between children using a manual toothbrush with visual pedagogy support and those using an AI-enabled electric toothbrush with app-based monitoring.
Detailed description
: Children with autism spectrum disorder (ASD) often face behavioral, motor, and sensory challenges that compromise their ability to perform effective toothbrushing. Caregivers are typically responsible for daily oral hygiene, yet few accessible digital or AI-based tools exist to support this process.
This study addresses this gap by combining two innovative approaches: visual pedagogy resources (picture exchange communication cards and tactile sensory panels) and an AI-enabled electric toothbrush with app-based monitoring. A randomized, parallel clinical trial will be conducted at the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP-USP), including 60 children aged 6-12 years with ASD. Participants will be randomized into two groups:
- Group 1: Manual toothbrushing with caregiver support and visual pedagogy materials.
- Group 2: AI-enabled electric toothbrush (Oral-B Genius X) with app-based feedback monitoring brushing time, pressure, and sequence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants are randomized into two parallel arms: manual toothbrushing with visual pedagogy vs. AI-enabled electric toothbrush.
| Arm | Type | Receives |
|---|---|---|
| Manual Toothbrushing + Visual Pedagogy | Active comparator | Behavioral: Visual Pedagogy and Manual ToothbrushingParticipants will use a manual toothbrush with caregiver support. Visual pedagogy materials will be provided, including printed picture exchange communication system (PECS) cards illustrating each step of toothbrushing and tactile sensory panels simulating toothbrush bristles, toothpaste texture, and dental floss. Caregivers will be instructed to use these materials daily to improve comprehension and adherence to toothbrushing routines. |
| AI-enabled Electric Toothbrush | Experimental | Behavioral: Visual Pedagogy and Manual ToothbrushingParticipants will use an Oral-B Genius X electric toothbrush equipped with artificial intelligence and Bluetooth connectivity. The device monitors brushing time, sequence, and pressure, providing real-time feedback through a smartphone application. Caregivers will be trained to supervise and encourage daily use at home for 3 weeks. The intervention aims to improve plaque removal and promote autonomy and motivation during oral hygiene in children with ASD. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Visual Pedagogy and Manual ToothbrushingAlso: Visual support materials, Picture Exchange Communication System (PECS), tactile sensory panelsParticipants in this arm will use a manual toothbrush with caregiver support. Visual pedagogy resources will include printed PECS cards illustrating each step of toothbrushing and tactile sensory panels simulating toothbrush bristles, toothpaste texture, and dental floss. Caregivers will be instructed to use these materials daily at home for 3 weeks to improve comprehension, adherence, and cooperation in children with ASD. | Behavioural | AI-enabled Electric Toothbrush, Manual Toothbrushing + Visual Pedagogy |
Primary outcome
Change in Plaque Index (Simplified Oral Hygiene Index - Greene & Vermillion)
Time frame: Baseline, Week 3, Week 6
Difference in gingival health between baseline and follow-up, assessed using the Löe and Silness Gingival Index. Higher scores indicate worse gingival condition.
1 secondary outcome
Bleeding on Probing (Community Periodontal Index)
Time frame: Baseline, Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Andiara De Rossi, DDS, PhD contact
Marilia Goulardins Gomes, DDS, MSc contact
Paulo Nelson Filho, DDS, PhD study director
Full Professor, Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto - USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Pedagogy and Manual Toothbrushing in people with Autism Spectrum Disorder and Child, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andiara De Rossi, DDS, PhD (andiara@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plaque Index (Simplified Oral Hygiene Index - Greene & Vermillion) (time frame: Baseline, Week 3, Week 6). 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 8 Sep 2025.