Orthodontic Treatment on Oral Microbiota and Salivary Proteins

N/ANot Yet RecruitingNCT06824493

Xi'an Jiaotong University150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Orthodontics White Spot Lesions [Initial Caries] on Smooth Surface of Tooth Caries, Dental

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No carries and White spot * No missing teeth * No history of oral treatment * No malocclusion * No systemic diseases Exclusion Criteria: * Antibiotic use in the past three months * A history of long-term medication use * A history of dental fillings * Unable to attend regular follow-ups

Outcomes

Primary Outcomes

Microbiota changes of plaque

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

Time frame: 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.

Microbiota changes of saliva

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

Time frame: Baseline, collect saliva at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.

Monitoring dental lesion progression

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

Time frame: Baseline, follow-up assessments are conducted at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.