Effectiveness of an Artificial Intelligence-Enabled Electric Toothbrush and Visual Pedagogy Materials on Oral Hygiene of Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Plaque Index (Simplified Oral Hygiene Index - Greene & Vermillion)
研究概览
简要总结
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.
详细描述
: 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking will be applied. Both participants and investigators will be aware of group allocation.
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Manual Toothbrushing + Visual Pedagogy
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.
干预措施: Visual Pedagogy and Manual Toothbrushing (Behavioral)
AI-enabled Electric Toothbrush
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.
干预措施: Visual Pedagogy and Manual Toothbrushing (Behavioral)
结局指标
主要结局
Change in Plaque Index (Simplified Oral Hygiene Index - Greene & Vermillion)
时间窗: 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.
次要结局
- Bleeding on Probing (Community Periodontal Index)(Baseline, Week 6)
研究者
Marília Goulardins
PhD Candidate in Pediatric Dentistry
University of Sao Paulo