Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in salivary microplastic abundance over time.
研究概览
简要总结
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
详细描述
This study is investigating whether orthodontic patients already scheduled to receive clear aligner treatment have changes in their microplastic exposure and physiologic uptake pre- and post-treatment. Consented and enrolled participants will provide unstimulated saliva and urine samples at three timepoints before regularly scheduled orthodontic appointments: Pre-treatment (Visit 1), 6-12 weeks post-treatment (Visit 2), and 16-24 weeks post-treatment (Visit 3). The saliva and urine samples will be filtered and then analyzed for microplastic content using mass spectroscopy, Raman spectroscopy and scanning electron microscopy approaches.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 75 years
- Receiving comprehensive, Phase II orthodontic treatment with clear aligner therapy
- Stable physical health (ASA I or II), as determined by study coordinator or PI
- Able to comprehend and follow requirements of study (including availability on scheduled visit dates)
- Patient and parental consent (and assent for minors) for participation in the study
排除标准
- Receiving orthodontic treatment with fixed appliances
- Receiving hybrid treatment with fixed appliances and aligners
- Receiving Phase I orthodontic treatment with fixed appliances
- Established history of severe xerostomia (dry mouth), severe periodontal disease with actively bleeding gums, significant oral abrasions/ulcers or growths, current alcohol abuse, and/or recreational drug abuse
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with participation
- Drinking, eating, or brushing teeth within 1 hour of study visit
- Removing aligners within 1 hour of study visit
- Developmental or cognitive disability such that the patient cannot self-consent, comprehend, and follow the requirements of the study based on research site personnel's assessment
结局指标
主要结局
Change in salivary microplastic abundance over time.
时间窗: Pre-treatment through 16-24 weeks post-treatment.
Differences in microplastic abundance in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Change in urinary microplastic abundance over time.
时间窗: Pre-treatment through 16-24 weeks post-treatment.
Differences in microplastic abundance in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
次要结局
- Change in urinary microplastic composition over time.(Pre-treatment through 16-24 weeks post-treatment.)
- Change in salivary microplastic composition over time.(Pre-treatment through 16-24 weeks post-treatment.)
- Change in salivary microplastic size over time.(Pre-treatment through 16-24 weeks post-treatment.)
- Change in urinary microplastic size over time.(Pre-treatment through 16-24 weeks post-treatment.)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06934603
- 其他研究编号
- 25-0426
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (8年后)
- 研究完成日期
- (8年后)
- 最近核实
- 最近更新
- (去年)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.