Comparison of Dimensional Accuracy and Color Stability Between Direct 3D-printed and Thermoformed Retainers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Surface Deviation (mm) Between Retainer STL and Original STL Reference Model Assessed by 3D Superimposition After 1 Month
研究概览
简要总结
This study aims to compare two types of orthodontic retainers used after active treatment to maintain teeth position. The retainers are fabricated using either direct 3D-printing or thermoforming methods. The study will evaluate which method provides better dimensional accuracy (fit) and color stability over time. Adult patients who have completed their orthodontic treatment will be randomly assigned to one of three groups, each receiving a different type of retainer. The research is conducted at the Faculty of Dental Medicine, Al-Azhar University - Assiut Branch. The goal is to help orthodontists select the most reliable and durable type of retainer for long-term use.
详细描述
This randomized clinical and laboratory study investigates the dimensional accuracy and color stability of orthodontic retainers fabricated using two different techniques: direct 3D printing and thermoforming. Patients who have completed active orthodontic treatment will be recruited and assigned to three groups. Group T1 will receive 3D-printed retainers, Group T2 will receive single-layer thermoformed retainers, and Group T3 will receive multi-layer thermoformed retainers...
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
- None
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
- •Patients who have completed their active orthodontic treatment.
- •Adults aged 18 years and above.
- •Cooperative individuals willing to participate.
- •Patients with good oral hygiene and general health.
- •No systemic diseases that may affect treatment outcomes.
排除标准
- •Patients with a history of poor compliance with previous orthodontic treatment.
- •Patients with parafunctional oral habits (e.g., bruxism).
- •Patients undergoing retreatment due to relapse.
研究组 & 干预措施
T1 - 3D-Printed Retainers
Participants in this group will receive retainers fabricated using direct 3D printing technology with bio-compatible clear resin.
干预措施: Direct 3D-Printed Retainer (Device)
T2 - Single-Layer Thermoformed Retainers
Retainers fabricated using thermoplastic sheets and a standard thermoforming machine.
干预措施: Single-Layer Thermoformed Retainer (Device)
T3 - Multi-Layer Thermoformed Retainers
Participants in this group will receive retainers fabricated using a multi-layer thermoforming method
干预措施: Multi-Layer Thermoformed Retainer (Device)
结局指标
主要结局
Mean Surface Deviation (mm) Between Retainer STL and Original STL Reference Model Assessed by 3D Superimposition After 1 Month
时间窗: 1 month after retainer delivery
Dimensional accuracy will be assessed by scanning each retainer and generating an STL file. The resulting STL will be superimposed on the original digital reference STL model using best-fit alignment in 3D inspection software (e.g., Geomagic Control X). The software will calculate the mean surface deviation in millimeters (mm). Results will be reported as mean ± standard deviation for each group (3D-printed vs thermoformed).
次要结局
- Color Change (ΔE) of Retainers Measured by Spectrophotometer Based on CIE L*a*b* System After 1 Month(1 month after retainer delivery)
研究者
Essraa hassan Hussein Mohamed
Master's Degree Candidate in Orthodontics
Al-Azhar University