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Not yet recruiting NCT07160517

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

No phase Interventional Autism Spectrum Disorder Child Oral Health Artificial Intelligence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visual Pedagogy and Manual Toothbrushing.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Child, Oral Health, Artificial Intelligence. Basic parameters: 5 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of an Artificial Intelligence-Enabled Electric Toothbrush and Visual Pedagogy Materials on Oral Hygiene of Children With Autism Spectrum Disorder

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Change in Plaque Index (Simplified Oral Hygiene Index - Greene & Vermillion) [Time frame: Baseline, Week 3, Week 6]
Secondary outcome measures (1)
  • Bleeding on Probing (Community Periodontal Index) [Time frame: Baseline, Week 6]

Eligibility 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Brazil · 1 center
  • School of Dentistry of Ribeirão Preto - University of São Paulo (FORP-USP) — Ribeirão Preto

Identifiers

NCT: NCT07160517 · CAAE80167324500005419

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗