CTRI/2025/08/093054招募中不适用
Comparative evaluation of biofilm microorganisms in patients treated with clear aligners and metal fixed orthodontic appliances: A prospective study.
Dr Roopa1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The awareness and understanding of oral hygiene aspects during orthodontic treatment using different appliances like metal fixed appliances, clear aligners will help the clinician to make a decision on the choice of orthodontic appliance for treating patients in a better manner with less adverse effects on gingival and periodontal health.
研究概览
简要总结
Comparing biofilm microorganisms in patients treated with clear aligners and metal fixed orthodontic treatment a prospective study at 2 time interval before (t0) and 6months after (t1) .
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 15.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient undergoing fixed metal orthodontic appliance treatment and clear aligner treatment.
- •2.No missing first molars and lateral incisors.
- •No crowns or fixed bridges
- •Healthy subjects without any systemic diseases and no active dental caries, no gingivitis and no periodontitis.
- •Before treatment, patients with periodontal probing depth less than 3mm and no periodontal attachment loss will be included
- •Have good oral hygiene and periodontal health
- •No intake of antibiotics or hormones 1 month before joining the study.
- •6.The gingival margin of the clear aligner is above the gingiva.
- •One month before baseline examination, all included patients underwent subgingival ultrasonic scaling.
排除标准
- •1 Patient with history of Xerostomia, hyposalivation.
- •2 Smokers and Pregnant women.
- •3 Subjects under any medications that could affect the antibiotic sensitivity during the previous six months before joining to study.
- •4 Patients who are under analgesic medication or NSAIDs will be excluded.
- •5 Cleft palate and cleft lip patients 6 Patients with ceramic brackets were excluded.
- •7 Due to ongoing H3N2outbreak, subjects with cough, cold, sore throat, breathlessness, fever or COVID symptoms will be excluded.
结局指标
主要结局
The awareness and understanding of oral hygiene aspects during orthodontic treatment using different appliances like metal fixed appliances, clear aligners will help the clinician to make a decision on the choice of orthodontic appliance for treating patients in a better manner with less adverse effects on gingival and periodontal health.
时间窗: at baseline(t1) , 6 months (t2)
次要结局
- To evaluate and compare the plaque and gingival indices during(treatment with metal fixed appliances and clear aligners.)
研究者
Dr Roopa
SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University
研究点 (1)
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