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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- White spot lesion area
研究概览
简要总结
In this study, it was intended to investigate the effect of nano Chitosan (antimicrobial agent) coating on clear aligner orthodontic appliance if it reduces the incidence of white spot lesions (demineralization) of enamel surfaces.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
White spot lesion area
时间窗: 3 months
It measures the area of enamel demineralization in pixels (Using the QLF system)
Mean of fluorescence loss (Delta F) in percent
时间窗: 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
次要结局
未报告次要终点