Orthodontic Treatment on Oral Microbiota and Salivary Proteins

Not yet recruiting

• Conditions: Orthodontics; White Spot Lesions [Initial Caries] on Smooth Surface of Tooth; Caries, Dental

• Registration Number: NCT06824493
• Lead Sponsor: Xi'an Jiaotong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-11
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-04
• Study Start: 2025-07-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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