Orthodontic Treatment on Oral Microbiota and Salivary Proteins

Condition(s) studied

Investigational drug(s) / intervention(s)

no interventions: no intervention as this is an observational studies

None-placebo: Observational study with no interventions

No Intervention: Observational Cohort: no intervention because of observational studies

Study summary

Study on the changes in oral microbiota during orthodontic treatment in patients aged 8-18 years. Orthodontic patients treated at Stomatology Hospital of Xi'an Jiaotong University from March 2025 to March 2027 will be recruited. Prior to orthodontic treatment, routine preoperative examinations will be conducted, informed consent forms will be signed, baseline oral conditions will be recorded, and oral and psychological-related questionnaires will be completed. Patients will be informed of the need for regular oral hygiene check-ups, caries risk assessments will be performed, and plaque, saliva, and intraoral photographs will be collected. During orthodontic treatment, plaque samples will be collected every 3 months, and saliva samples will be collected every 6 months until the treatment is completed to evaluate the changes in oral microbiota throughout the orthodontic process.

Eligibility

Primary outcome measure(s)

• Microbiota changes of plaque — baseline, collect plaque in the first month, then at Month 3, 6, 9, 12, 15, 18, 21, 24, 27,30 through study completion, an average of 30 months.
  Samples of supragingival plaques will proceed to 16S rRNA sequencing for analysis of microbiome profiles, and q-PCR for evaluating bacterial loads of some critical pathogens for dental caries
• Microbiota changes of saliva — Baseline, collect saliva at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.
  Samples of saliva will proceed to 16S rRNA sequencing for analysis of microbiome profiles, and q-PCR for evaluating bacterial loads of some critical pathogens for dental caries
• Monitoring dental lesion progression — Baseline, follow-up assessments are conducted at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.
  ICDAS(International Caries Detection and Assessment System) scoring system helps in detecting early caries, monitoring lesion progression, and developing tailored treatment strategies. Scoring Criteria: 0: No visible caries; 1: First visual change (only visible when dry); 2: Distinct visual change (visible without drying); 3: Initial enamel breakdown;4: Underlying dark shadow from dentin;5: Moderate cavity with dentin exposure; 6: Extensive cavity with pulp involvement

Trial sites (1)

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