Analyzing microplastic release from orthodontic aligners : An In-vivo approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The study found that PET, PETG, and PU aligners release
研究概览
简要总结
Clear orthodontic aligners are widely popular due to their aesthetic appeal and functional advantages. However, concerns about the release of microplastics (MPs) from these aligners have emerged, as plastic materials are susceptible to mechanical degradation. Ingesting MPs has been associated with oxidative stress, inflammatory lesions, and other health issues, including disruptions to gut microbiota, respiratory complications, cardiovascular risks, and cognitive function. This study investigates the in-vivo release of MPs from orthodontic aligners made of polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), and polyurethane (PU), with a control group of patients using traditional metal braces.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with moderate to mild orthodontic malocclusions requiring clear aligner treatment
- •Ability to commit to regular follow-up appointments for the duration of the study.
- •Non-smokers to eliminate potential confounding factors related to oral health and material degradation
- •No known allergies or sensitivities to materials used in orthodontic aligners (PET, PETG, PU).
排除标准
- •Patients with severe malocclusions requiring non-clear aligner treatment options such as surgery
- •Patients with a history of allergic reactions to materials used in clear aligners (PET, PETG, PU)
- •Patients with temporomandibular joint disorders (TMD) that may affect aligner wear or exacerbate discomfort during treatment.
结局指标
主要结局
The study found that PET, PETG, and PU aligners release
时间窗: 3 months
microplastics, with varying amounts, while metal braces
时间窗: 3 months
showed no microplastic release, emphasizing health and
时间窗: 3 months
sustainability concerns.
时间窗: 3 months
次要结局
未报告次要终点
研究者
Karthick P
Chettinad Dental College and Research Institute