Oral Microecology in Children With Autism

NCT07538232 | Completed DMC

• 1 other identifier: 2024-152（R）
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a non-interventional research aimed at investigating the oral microbiota distribution and salivary IgA in children with autism by collecting dental plaque and saliva for analysis, without involving experimental content

Conditions

Autism; Caries,Dental

Outcome Measures

Primary Outcomes (1)

• sequencing of 16s rRNA

  sequencing of 16s rRNA

  2024-2026

Secondary Outcomes (2)

• IgA

  2024-2026

• DMFT/dmeft

  2024-2026

Study Arms (2)

autism group

children with autism aged 6-18 years

TD group

typically developed children aged 6-18 years

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children with autism aged 6-18 years old

You may qualify if:

• Clear source: This project is supported by the Affiliated Dental Hospital of Zhejiang University School of Medicine;
• Make sure to collect all patients' age, gender, and basic test information. The age range is 6-18 years old, and there is no restriction on gender; ③ The subjects and/or their families are able to understand the purpose of the trial, are willing to cooperate, and voluntarily or/and with the consent of their families, agree to participate in the trial and sign the informed consent form.

You may not qualify if:

• Magnetic resonance imaging detected significant abnormalities in brain structure;
• Severe sensory organ damage (blindness, hearing loss); ③ Having organic gastrointestinal problems;
• Taking antibiotics or immunosuppressive drugs within one month;
• Autism and other conditions that have been clearly linked to genetics; ⑥ Obvious abnormalities in oral mucosa; ⑦ Wearing various orthodontic appliances and accessories.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Conditions

Autistic Disorder; Dental Caries

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: November 24, 2024
• Primary Completion: September 20, 2025
• Study Completion: March 20, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)