Health TrialsbyHealthPanel

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

ConditionsAutism Spectrum DisorderChildOral HealthArtificial Intelligence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-13
SponsorUniversity of Sao Paulo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Manual Toothbrushing + Visual PedagogyActive comparator 1 intervention
Group B: AI-enabled Electric ToothbrushExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline, Week 3, Week 6

Secondary outcomes

1

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

Other outcomes

1

Caregiver-Reported Adherence and Motivation

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

Time frame
Baseline, Week 6
2

Usability of Digital Platform (System Usability Scale - SUS)

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.

Time frame
After 3 weeks of use

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: