NCT07617571尚未招募不适用
Bone Metabolism in Patients Treated With 3d Printed Aligners Versus Thermoformed Aligners (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Background: Orthodontic forces induce tissue reactions by triggering perturbations from orthodontic appliances, which lead to the modelling and remodelling of alveolar bone. Despite the growing popularity of 3D-printed aligners, no studies have compared their effects on bone metabolism in comparison with thermoformed aligners. Aim: This study aims to assess bone metabolism in patients undergoing treatment with 3D-printed aligners versus thermoformed aligners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patients will be blinded at appliance delivery, to reduce the risk of bias. Moreover, the biologist in the laboratory who will do the measurements, and the statistician will be blinded to the nature of the study.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minor malocclusion (2 to 4 mm of crowding) .
- •Patients in need for Antero-posterior expansion and labial tipping of incisors without interproximal reduction
- •No use of anti-inflammatory drugs or antibiotics in the past 6 months.
- •Periodontal parameters of gingival index <1 and no pocketing with a generalized pocketing depth of <3mm.
- •Radiographic parameters of no crestal bone loss.
- •No history of smoking.
排除标准
- •Signs of inflammation of the gingiva, and periodontitis.
- •Systemic conditions (kidney disease, HIV, and liver disease).
- •Teeth missing or poor oral hygiene.
- •Bone disease e.g.; osteoporosis.
研究者
研究点 (1)
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