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

NCT07160517 | Not Yet Recruiting

• 1 other identifier: CAAE80167324500005419
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Child; Oral Health; Artificial Intelligence

Keywords

Autism Spectrum Disorder, Toothbrushing, Oral Hygiene, Artificial Intelligence.

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 3, Week 6

Secondary Outcomes (1)

• Bleeding on Probing (Community Periodontal Index)

  Baseline, Week 6

Other Outcomes (2)

• Caregiver-Reported Adherence and Motivation

  Baseline, Week 6

• Usability of Digital Platform (System Usability Scale - SUS)

  After 3 weeks of use

Study Arms (2)

Manual Toothbrushing + Visual Pedagogy

ACTIVE COMPARATOR

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.

Behavioral: Visual Pedagogy and Manual Toothbrushing

AI-enabled Electric Toothbrush

EXPERIMENTAL

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.

Behavioral: Visual Pedagogy and Manual Toothbrushing

Interventions

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.

Also known as: Visual support materials, Picture Exchange Communication System (PECS), tactile sensory panels

AI-enabled Electric Toothbrush; Manual Toothbrushing + Visual Pedagogy

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14040907, Brazil

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Paulo Nelson Filho, DDS, PhD

  Full Professor, Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto - USP

  STUDY DIRECTOR

Central Study Contacts

Andiara De Rossi, DDS, PhD

CONTACT

andiara@usp.br

Marilia Goulardins Gomes, DDS, MSc

CONTACT

m_goulardins@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied. Both participants and investigators will be aware of group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate in Pediatric Dentistry

Model Details: participants are randomized into two parallel arms: manual toothbrushing with visual pedagogy vs. AI-enabled electric toothbrush.

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): February 10, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

BR (1)