Orthodontic Treatment on Oral Microbiota and Salivary Proteins
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Microbiota changes of plaque
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No carries and White spot
- •No missing teeth
- •No history of oral treatment
- •No malocclusion
- •No systemic diseases
排除标准
- •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
研究组 & 干预措施
ID number
干预措施: None-placebo (Other)
ID number
干预措施: No Intervention: Observational Cohort (Other)
ID number
干预措施: no interventions (Other)
结局指标
主要结局
Microbiota changes of plaque
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Shanshan-Dai
attending physician of pediatric dentist and PhD in Orthodontics
Xi'an Jiaotong University