[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605284":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":55,"collaborators":36,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":36,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":36,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":84,"whyStopped":36,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Visual Pedagogy and Manual Toothbrushing",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Visual Pedagogy and Manual Toothbrushing","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.",[15,9],[26],"Visual support materials, Picture Exchange Communication System (PECS), tactile sensory panels",[28],{"name":29,"affiliation":30,"role":31},"Paulo Nelson Filho, DDS, PhD","Full Professor, Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto - USP","STUDY_DIRECTOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":36,"email":37},"Andiara De Rossi, DDS, PhD","CONTACT",null,"andiara@usp.br",{"name":39,"role":35,"phone":36,"phoneExt":36,"email":40},"Marilia Goulardins Gomes, DDS, MSc","m_goulardins@yahoo.com.br",[42],{"facility":43,"status":36,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":36},"School of Dentistry of Ribeirão Preto - University of São Paulo (FORP-USP)","Ribeirão Preto","São Paulo","14040907","Brazil","BR",{"type":50,"coordinates":51},"Point",[52,53],-47.81028,-21.1775,{"lat":53,"lon":52},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Marília Goulardins","PhD Candidate in Pediatric Dentistry","100605284","ai-toothbrush-and-visual-pedagogy-to-improve-oral-hygiene-in-children-with-autism-spectrum-disorder-100605284",false,"NCT07160517","AI Toothbrush and Visual Pedagogy to Improve Oral Hygiene in Children With Autism Spectrum Disorder","Effectiveness of an Artificial Intelligence-Enabled Electric Toothbrush and Visual Pedagogy Materials on Oral Hygiene of Children With Autism Spectrum Disorder","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.\n\nChild must be accompanied by a primary caregiver (≥18 years old) responsible for daily oral hygiene.\n\nCaregiver must have access to a smartphone or computer to interact with the digital platform.\n\nWritten informed consent (TCLE) from the caregiver and assent (TALE) from the child.\n\n\\-\n\nExclusion Criteria:Severe systemic medical conditions that contraindicate participation in clinical oral evaluations.\n\nChildren with advanced periodontal disease or other oral conditions requiring urgent dental treatment.\n\nCaregivers who are unable or unwilling to use basic digital platforms (smartphone, tablet, or computer).\n\nFamilies who decline participation at any stage of the study.\n\n\\-",true,"ALL","5 Years","13 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78,79,80,81],"Autism Spectrum Disorder","Child","Oral Health","Artificial Intelligence",[83],"Autism Spectrum Disorder, Toothbrushing, Oral Hygiene, Artificial Intelligence.","NOT_YET_RECRUITING","2025-08-29",{"date":87,"type":88},"2025-09-08","ACTUAL",{"date":90,"type":72},"2025-10-01",{"date":92,"type":72},"2027-02-10",{"name":5,"class":6},1]