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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.
: 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Pedagogy and Manual Toothbrushing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 3, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on Probing (Community Periodontal Index) | Assessment of bleeding on probing at six index teeth sites, following WHO Community Periodontal Index criteria. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver-Reported Adherence and Motivation | Questionnaire responses evaluating caregiver perceptions of the child's motivation, autonomy, and adherence to oral hygiene routines. | Baseline, Week 6 |
| Usability of Digital Platform (System Usability Scale - SUS) |
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andiara De Rossi, DDS, PhD | Contact | andiara@usp.br | ||
| Marilia Goulardins Gomes, DDS, MSc | Contact | m_goulardins@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Paulo Nelson Filho, DDS, PhD | Full Professor, Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto - USP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry of Ribeirão Preto - University of São Paulo (FORP-USP) | Ribeirão Preto | São Paulo | 14040907 | Brazil |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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participants are randomized into two parallel arms: manual toothbrushing with visual pedagogy vs. AI-enabled electric toothbrush.
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No masking will be applied. Both participants and investigators will be aware of group allocation.
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Usability and acceptability of the caregiver support digital platform, assessed by the 10-item System Usability Scale (SUS). Scores range from 0 to 100; scores above 68 indicate good usability.
| After 3 weeks of use |