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NCT Number: NCT07160517

AI Toothbrush and Visual Pedagogy to Improve Oral Hygiene in 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.

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Key information

Conditions

Autism Spectrum Disorder Artificial Intelligence Child Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Oral Health

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry of Ribeirão Preto - University of São Paulo (FORP-USP)

Ribeirão Preto, São Paulo, 14040907, Brazil

About this study

: 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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.

Other names: Visual support materials, Picture Exchange Communication System (PECS), tactile sensory panels

Primary outcomes

  1. 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.

Secondary outcomes

  1. Bleeding on Probing (Community Periodontal Index)

    Time frame: Baseline, Week 6

    Assessment of bleeding on probing at six index teeth sites, following WHO Community Periodontal Index criteria.

Other outcomes

  1. Caregiver-Reported Adherence and Motivation

    Time frame: Baseline, Week 6

    Questionnaire responses evaluating caregiver perceptions of the child's motivation, autonomy, and adherence to oral hygiene routines.

  2. Usability of Digital Platform (System Usability Scale - SUS)

    Time frame: After 3 weeks of use

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andiara De Rossi, DDS, PhD

CONTACT

[email protected]

Marilia Goulardins Gomes, DDS, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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