AI Toothbrush and Visual Pedagogy to Improve Oral Hygiene in Children With Autism Spectrum Disorder
NCT ID: NCT07160517
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-10-01
2027-02-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Manual Toothbrushing + Visual Pedagogy
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.
Visual Pedagogy and Manual Toothbrushing
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.
AI-enabled Electric Toothbrush
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.
Visual Pedagogy and Manual Toothbrushing
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.
Interventions
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Visual Pedagogy and Manual Toothbrushing
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
\-
Exclusion Criteria
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.
\-
5 Years
13 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Marília Goulardins
PhD Candidate in Pediatric Dentistry
Principal Investigators
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Paulo Nelson Filho, DDS, PhD
Role: STUDY_DIRECTOR
Full Professor, Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto - USP
Locations
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School of Dentistry of Ribeirão Preto - University of São Paulo (FORP-USP)
Ribeirão Preto, São Paulo, Brazil
Countries
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Central Contacts
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Other Identifiers
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CAAE80167324500005419
Identifier Type: -
Identifier Source: org_study_id
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