Material and Clinical Assessment of 3D-printed vs. Milled Occlusal Splints: A Study on Performance and Durability in Dental Applications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comfort
研究概览
简要总结
This crossover study aims to evaluate the wear comfort, retention, and stability of 3D-printed and milled occlusal splints in healthy subjects.
The main question it aims to answer is:
Research questions
- How do healthy subjects experience the wear comfort, fitting, retention and stability of a printed and milled occlusal splint? and how do clinicians experience the fitting, retention and stability of the splints?
By systematically assessing self-reported outcomes, this research seeks to contribute valuable insights into the practical applications of both technologies. The findings may not only enhance our understanding of patient preferences but also guide future developments in the design and manufacturing of occlusal splints, ultimately improving patient care in dental practice.
详细描述
The main study parameter is to assess the participant self-reported findings regarding the comfort, retention, stability and fit of the milled and printed splint and in addition to the hygiene and discoloration of the splint over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects being healthy (ASA <IV)
- •Subjects with healthy, complete dentitions (except for extractions of wisdom teeth, or tooth extractions for the purpose of orthodontic treatment in the past)
- •Subjects willing and able to participate in the study
- •Subjects willing to provide written informed consent for their participation in the study
排除标准
- •Subjects with dental issues other than the inclusion criteria
- •Subjects with a history of autoimmune disorder
- •Subjects with known allergies to acrylic materials
- •Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g., asthma) and subjects with an active infection of any kind at the time of enrollment
- •Subjects who are pregnant or lactating
- •Subjects enrolled in another investigational clinical trial
结局指标
主要结局
Comfort
时间窗: "From enrollment to the end of treatment at 6 weeks"
Self reported wear comfort by filling in a questionnaire. This scale measures the comfort of the occlusal splint, where "Very uncomfortable" represents the worst experience (lowest score) and "Very comfortable" represents the best experience (highest score). Minimum Value: Very uncomfortable, Maximum Value: Very comfortable. Higher Scores Mean: Better comfort (more comfort)
次要结局
- Stability(From enrollment to the end of treatment at 6 weeks)
- Perceived Retention of Occlusal Splint on Model(From enrollment to end of treatment at six weeks)
- Perceived Retention of Occlusal Splint During Wear(From enrollment to the end of treatment at six weeks.)
- Perceived Fit of the Occlusal Splint on the Model and in the Mouth(From enrollment to end of the treatment at six weeks.)
- Perceived Fit of the Occlusal Splint on Teeth(From enrollment to end of the treatment at six weeks)
- Cleanability(From enrollment to the end of treatment at 6 weeks.)
- Occlusion(From enrollment to the end of treatment at 6 weeks.)