3D-Printed and Thermoformed Clear Aligners: Analysis of Adaptation and Trueness.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Aligner-tooth adaptation (3D gap distance) for each clear aligner system, with and without attachments.
研究概览
简要总结
This prospective clinical study aims to evaluate and compare the in vivo adaptation and trueness of clear aligners fabricated using thermoforming and direct three-dimensional (3D) printing technologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 18 years or older.
- •Good general and oral health.
- •Dentition adequate to support passive upper clear aligner wear, as determined by the investigator.
- •Willing and able to attend all study visits over the 4-6 month study period.
- •Willing and able to comply with aligner wear and all study procedures.
- •Able to provide written informed consent and HIPAA authorization.
排除标准
- •Active dental or periodontal disease, or any oral condition that could interfere with study procedures.
- •Need for active orthodontic treatment or other dental procedures during the study period.
- •Poor oral hygiene or failure to follow study instructions at the screening visit.
- •Medical or systemic conditions, or use of medications, that could compromise participation or study outcomes.
- •Concurrent participation in another interventional research study.
- •Pregnancy or planned pregnancy during the study period (if applicable).
研究组 & 干预措施
No attachment group
Attachment group
干预措施: Device: Invisalign Passive Clear Aligner (Device)
Attachment group
干预措施: Spark Passive aligners (Device)
Attachment group
干预措施: Zendura passive aligner (Device)
Attachment group
干预措施: Graphy passive aligner (Device)
Attachment group
干预措施: Luxcreo passive aligner (Device)
结局指标
主要结局
Aligner-tooth adaptation (3D gap distance) for each clear aligner system, with and without attachments.
时间窗: Up to 14 days of wear for each aligner system (assessed at baseline, 24 hours, 7 days, and 14 days).
Mean 3D distance (millimeters) between the inner surface of the passive clear aligner and the corresponding tooth surface, computed from superimposed digital intraoral scans at baseline, 24 hours, 7 days, and 14 days of wear for each aligner system, comparing attachment and non-attachment groups
次要结局
未报告次要终点