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Prospective Registry Study on Perioperative Neurobehavior and Functional Outcomes in Children with Autism Spectrum Disorder Undergoing Dental Treatment under General Anesthesia

Prospective Registry Study on Perioperative Neurobehavior and Functional Outcomes in Children with Autism Spectrum Disorder Undergoing Dental Treatment under General Anesthesia

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125259
Enrollment
Unknown
Registered
2026-05-24
Start date
2026-05-24
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

ASD Cohort:None
Control Cohort:None

Sponsors

Wenzhou Medical University School of Stomatology & Affiliated Stomatological Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: ASD group 1. Aged 2-17 years ASD group 2. Prior diagnosis of Autism Spectrum Disorder by a medical institution or professional assessment agency, with at least one of the following supporting documents: (a) ASD diagnostic report or medical record issued by a medical institution; (b) Disability certificate specifying autism; (c) Special education school enrollment certificate; (d) Rehabilitation institution registration certificate or assessment report. Patients whose parents clearly report a prior diagnosis but cannot provide any written documentation may still be enrolled, marked as verbal report only, and subjected to sensitivity analysis ASD group 3. Scheduled for elective dental treatment under general anesthesia at our hospital (including caries restoration, pulp therapy, extraction, and other routine dental procedures) ASD group 4. ASA physical status classification I-III ASD group 5. Written informed consent from legal guardian Control group 1. Aged 2-17 years Control group 2. No parent-reported diagnosis or clinical suspicion of ASD or other neurodevelopmental disorders (ADHD, intellectual disability, language developmental disorder, etc.) Control group 3. Scheduled for elective dental treatment under general anesthesia at our hospital Control group 4. ASA physical status classification I-II Control group 5. Written informed consent from legal guardian

Exclusion criteria

Exclusion criteria: 1. Severe congenital heart disease, uncontrolled epilepsy (=2 seizures within the past 3 months), or other serious systemic diseases that may affect the safety of general anesthesia 2. Severe hearing or visual impairment that would affect perioperative behavioral assessment 3. Known genetic metabolic diseases (phenylketonuria, mitochondrial disease, Rett syndrome, Fragile X syndrome, etc.) 4. Emergency surgery 5. Legal guardian unable to complete postoperative follow-up (no telephone or WeChat contact) 6. Legal guardian refuses to participate or withdraws informed consentS

Design outcomes

Primary

MeasureTime frame
Incidence and severity of emergence delirium;Postoperative behavioral changes;Preoperative anxiety ;

Secondary

MeasureTime frame
Anesthesia induction compliance;Change in oral health-related quality of life;Postoperative changes in ASD core symptom domains;Changes in sleep patterns;Parental anxiety and caregiver burden;Longitudinal changes in social function and sensory processing;

Countries

China

Contacts

Public ContactZhu Ge Jinru

School and Hospital of Stomatology, Wenzhou Medical University

zhugejinru1993@163.com+86 158 5777 2741

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026