Integrated Multi-Omics Analysis of the Oral–Gut Microbiome in Adolescents During the Early Phase of Fixed Orthodontic Treatment

Integrated Multi-Omics Analysis of the Oral–Gut Microbiome in Adolescents During the Early Phase of Fixed Orthodontic Treatment - Orthodontics

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600121223

Enrollment

Unknown

Registered

2026-03-26

Start date

2025-01-25

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Adolescent Patients with Malocclusion

Interventions

Observation Group:None

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Adolescents aged 12–18 years. 2.Both male and female patients. 3.Residing in the urban area of Longyan City or surrounding regions (to facilitate follow-up). 4.Patients with malocclusion requiring fixed orthodontic treatment. 5.Angle Class I or Class II malocclusion. 6.Planned treatment with straight-wire appliance therapy. 7.In the permanent dentition stage. 8.Caries-free or with carious lesions that had been appropriately restored. 9.Periodontal health, with probing depth <=3 mm. 10.Good oral hygiene habits. 11.No oral mucosal lesions. 12.Systemically healthy. 13.Body mass index (BMI) within the normal range. 14.No use of antibiotics within the previous 3 months. 15.Normal dietary habits. 16.Provision of informed consent by both the patient and their legal guardian. 17.Ability to comply with the entire follow-up protocol. 18.Ability and willingness to provide all samples required for the study.

Exclusion criteria

Exclusion criteria: 1.Presence of diabetes mellitus or autoimmune diseases. 2.Gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome, etc.). 3.Immune system diseases. 4.Endocrine disorders. 5.Use of antibiotics within the previous 3 months. 6.Long-term use of immunosuppressive agents. 7.Currently receiving other treatments that may affect the oral or gut microbiota. 8.Active dental caries. 9.Severe periodontitis (probing depth > 5 mm). 10.Oral mucosal diseases. 11.History of previous orthodontic treatment. 12.Smoking or alcohol consumption. 13.Strict vegetarians (including vegans). 14.Special dietary patterns (e.g., ketogenic diet, etc.). 15.Regular use of vitamins or dietary supplements. 16.Pregnancy or planning to become pregnant. 17.Poor compliance, with inability to attend scheduled follow-up visits. 18.Psychiatric disorders or cognitive impairment. 19.Participation in other clinical studies.

Design outcomes

Primary

Measure	Time frame
Metagenomic Sequencing Analysis;Metabolomic Analysis;	—

Countries

China

Contacts

Public ContactWu Jinmei

Longyan First Hospital

m13665072114@163.com+86 136 6507 2114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026