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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07160517
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-10-01
• Primary Completion: 2026-08-15
• Study Completion: 2027-02-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Plaque Index (Simplified Oral Hygiene Index - Greene & Vermillion)	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 Outcome Measures

Name	Time	Method
Bleeding on Probing (Community Periodontal Index)	Baseline, Week 6	Assessment of bleeding on probing at six index teeth sites, following WHO Community Periodontal Index criteria.

Trial Locations

Locations (1)

School of Dentistry of Ribeirão Preto - University of São Paulo (FORP-USP); 🇧🇷 Ribeirão Preto, São Paulo, Brazil