Randomized Cross-clinical Trial Comparing Precision of Conventional Stabilization Splints (Michigan Type) Versus CAD/CAM Splints With Fully Digital Flow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of occlusal contacts
研究概览
简要总结
This is a randomized controlled trial with a crossover design, which intends to enroll 20 adult patients aged between 20 and 55 years with confirmed or probable sleep bruxism. Participants will be randomized to receive either a conventional stabilization splint or a CAD/CAM splint. Each patient will use one type of splint for 30 days, followed by a 15-day wash-out period, after which they will switch to the other type of splint. The study aims to compare the quality, precision, and comfort of the two types of occlusal splints. Outcomes will include manufacturing time, amount of in-mouth adjustments, adaptation, occlusal contacts, and participant satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant Masking:
Patients will not be informed whether they are receiving the conventional stabilization splint or the CAD/CAM splint. The splints will be marked with small, inconspicuous letters (A for Group A and B for Group B) during the fabrication process to minimize the possibility of the patients identifying which type of splint they are using. Additionally, both splints will be polished similarly to ensure no noticeable differences in appearance or texture.
Researcher Masking:
The primary researcher conducting patient evaluations and data analysis will be blinded to the group assignments. This researcher will not be involved in the fabrication or fitting of the splints, thereby maintaining an objective perspective during assessments.
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged between 20 and 55 years.
- •Probable or confirmed diagnosis of sleep bruxism.
- •No previous treatment with occlusal splints.
- •Absence of periodontal diseases and/or dental fractures.
- •Patients must have a minimum of 28 teeth.
排除标准
- •Patients with systemic diseases affecting the temporomandibular joint, such as rheumatoid arthritis, osteoarthritis, and osteoporosis.
- •Chronic users of medications that may interfere with the study results, including analgesics, anti-inflammatory drugs, anxiolytics, antidepressants, and anticonvulsants.
- •Patients with a history of temporomandibular joint surgery.
- •Pregnant or breastfeeding women.
- •Patients with severe dental misalignment or malocclusion that would affect splint fitting and evaluation.
研究组 & 干预措施
Digital occlusal splints (CAD/CAM)
Patients in this arm will receive a CAD/CAM occlusal stabilization splint created using a fully digital workflow. The process includes:
- Digital Impression: digital scan of the mouth will be performed using a 3shape® intraoral scanner.
- Digital Design: The scanned data will be processed using Dental Wings' DWOS® software to design the occlusal splint virtually. The design will ensure the splint follows the Michigan splint type specifications.
- Manufacturing: The designed splint will be fabricated using a Straumann® P series rapidshape P30+ 3D printer with a specific acrylic resin, Cosmos Splint. The splint will be polished to ensure comfort and fit, while maintaining the same surface texture as the conventional splint.
- Fitting and Adjustment: The digitally fabricated splint will be fitted and adjusted as necessary to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process.
干预措施: Digital occlusal splints (CAD/CAM) (Device)
Conventional occlusal splints
Patients in this arm will receive a conventional occlusal stabilization splint fabricated using traditional analog methods. The process includes:
- Impression Taking: Impressions of the patient's upper and lower arches will be taken using alginate.
- Model Preparation: The plaster models will be mounted on a semi-adjustable articulator using a centric relation occlusal record. A wax-up of the occlusal splint will be created following the Michigan splint type specifications.
- Manufacturing: The wax-up will be processed and flasked with heat-cured acrylic resin to create the final splint. The splint will be polished similarly to the digital splint to ensure a consistent appearance and texture.
- Fitting and Adjustment: The conventional splint will be fitted and adjusted to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process.
干预措施: Conventional occlusal splints (Device)
结局指标
主要结局
Number of occlusal contacts
时间窗: Immediately after the initial installation
The number of occlusal contacts will be measured using the OccluSense® device
次要结局
- Time Required for Splint Adjustment(Immediately after the initial installation and adjustment)
- Participant satisfaction after 30 days(After 30 days of use)
- Splint comfort after installation(Immediately after the initial installation and adjustment)
- Splint stability after 30 days(After 30 days of use)
- Participant satisfaction after installation(Immediately after the initial installation and adjustment)
- Splint comfort after 30 days(After 30 days of use)
- Splint stability after installation(Immediately after the initial installation and adjustment)