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

N/ANot Yet RecruitingNCT07160517

University of Sao Paulo50 enrolled

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.

: 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Autism Spectrum Disorder

Interventions

Visual Pedagogy and Manual ToothbrushingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. \- 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. \-

Outcomes

Primary Outcomes

Change in Plaque Index (Simplified Oral Hygiene Index - Greene & Vermillion)

Difference in gingival health between baseline and follow-up, assessed using the Löe and Silness Gingival Index. Higher scores indicate worse gingival condition.

Time frame: Baseline, Week 3, Week 6

Secondary Outcomes

Bleeding on Probing (Community Periodontal Index)

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

Time frame: Baseline, Week 6