The Effect of Nano Chitosan Surface Coating on White Spot Lesions Development in Clear Aligner Therapy Patients
The Effect of Nano Chitosan Carboxymethyle Methyle Cellulose Surface Coating on White Spot Lesions Development in Patients With Clear Aligner Therapy: Prospective Randomized Controlled Clinical Trial
研究概览
详细说明
White spot lesions (WSLs) are a common complication of orthodontic treatment and represent the earliest stage of enamel demineralization. Although clear aligner therapy is generally associated with a lower risk of WSL development than fixed appliances, enamel demineralization may still occur during treatment. Chitosan nanoparticles possess antimicrobial properties and have shown potential for preventive dental applications. This study investigated the effectiveness of chitosan nanoparticle-coated clear aligners in limiting enamel demineralization during orthodontic treatment.
A prospective two-arm parallel-group randomized controlled clinical trial was conducted on 53 patients (18-29 years) undergoing clear aligner therapy. Participants were randomly allocated into two groups: conventional clear aligners (control) and chitosan nanoparticle-coated clear aligners (experimental). Three participants were lost to follow-up, and 50 patients (25 per group) were included in the final analysis. Chitosan nanoparticles were prepared using ionic gelation and applied to aligner surfaces following atmospheric plasma treatment. Surface characterization was performed using profilometry, scanning electron microscopy (SEM), and energy-dispersive X-ray analysis (EDAX). White spot lesions were assessed at baseline and after six months using quantitative light-induced fluorescence (QLF)
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Irbid、约旦、22110
- Postgraduate Orthodontic Clinics
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-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Patients presenting with mild to moderate malocclusion (sagittal, vertical, transverse discrepancies, or crowding) that could be treated using clear aligners within a maximum treatment period of one year and without the need for extraction therapy.
- Medically healthy patients with no systemic diseases or medical conditions that could affect enamel integrity, salivary flow, oral hygiene status, or periodontal health.
- Patients with no history of previous orthodontic treatment, dental trauma, or parafunctional habits such as bruxism.
- Patients with good oral hygiene and absence of active periodontal disease, including gingivitis or periodontitis.
- Patients willing to comply with the prescribed clear aligner wear protocol for a minimum of 22 hours per day.
- Patients who agreed to participate in the study and signed the informed consent form.
Exclusion Criteria:
- Previous orthodontic treatment that could influence baseline enamel condition or white spot lesion assessment.
- Presence of active carious lesions, cavitated lesions, severe enamel hypoplasia, or developmental enamel defects.
- Extensive restorations on anterior teeth that could interfere with Quantitative Light-Induced Fluorescence (QLF) imaging and analysis.
- Systemic diseases or medical conditions affecting salivary flow, enamel integrity, oral hygiene, or periodontal health.
- Use of medications known to affect salivary secretion, enamel mineralization, or oral microbial balance.
- Poor oral hygiene or presence of active periodontal disease, including gingivitis or periodontitis.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Intervention
Chitosan nanoparticle coating of the clear orthodontic aligners that will be used by the participants
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Clear orthodontic aligners will be coated with nanoparticle sized Chitosan to investigate its anti-microbial effect on development of white spot lesions underneath the aligners
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安慰剂比较:Control
The clear orthodontic aligners that will be used by the participants are not coated with anything.
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No coating of the orthodontic aligners
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
White spot lesion area
大体时间:3 months
|
It measures the area of enamel demineralization in pixels (Using the QLF system)
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3 months
|
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Mean of fluorescence loss (Delta F) in percent
大体时间:3 months
|
It measures the percentage of fluorescence loss in the white spot lesion compared to that of sound enamel reflecting the amount of mineral loss using the QLF system
|
3 months
|
合作者和调查者
调查人员
- 研究主任:Susan Al-Khateeb、Jordan University of Science and Technology
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- JUST20250008
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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