AI Toothbrush and Visual Pedagogy to Improve Oral Hygiene in Children With Autism Spectrum Disorder

University of Sao Paulo

Status: Not yet enrolling

Conditions: Child; Autism Spectrum Disorder; Artificial Intelligence; Oral Health

Treatments: Behavioral: Visual Pedagogy and Manual Toothbrushing

Study type: Interventional

Funder types: Other

Identifiers

NCT07160517

CAAE80167324500005419

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Manual Toothbrushing + Visual Pedagogy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Visual Pedagogy and Manual Toothbrushing

AI-enabled Electric Toothbrush

Experimental group

Description:

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.

Treatment:

Behavioral: Visual Pedagogy and Manual Toothbrushing