Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- 1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).
研究概览
简要总结
This randomized controlled research aimed to analyse the occlusion and assist the enamel wear before and after using of the stabilization splints produced by the conventional methods with the fully digitally fabricated stabilization splints.
Research question: Will the fully digital stabilization splint offer significantly better occlusal equilibration and enamel wear compared to the conventional stabilization splint? the primary outcome will be Digital occlusal analysis, and secondary outcome will be enamel wear assessment
详细描述
This randomized controlled clinical trial investigates the effectiveness of fully digitally fabricated stabilization splints (FD-SS) versus conventionally manufactured stabilization splints (C-SS) in patients with temporomandibular disorders (TMD). The study focuses on two primary outcomes: digital occlusal analysis and enamel wear assessment over a 6-month period.
Participants are TMD patients aged 18-40 with stable jaw relations and intact dentition, randomly assigned (1:1) to the FD-SS or C-SS group. Digital occlusal analysis is performed using OccluSense technology, which captures bite force distribution and contact points dynamically and statically. Enamel wear is assessed quantitatively using an intraoral scanner paired with Geomagic Control X 3D software for surface matching analysis. Baseline and follow-up STL datasets are compared to quantify volumetric enamel loss with micrometer precision.
In the FD-SS group, fully digital stabilization splints are fabricated using a digital workflow that includes intraoral scanning, jaw tracking with Zebris JMA devices, and CAD/CAM design in Exocad software. Splints are manufactured using 3D printing technology. In the C-SS group, conventional splints are fabricated using alginate impressions, plaster casts, and manual adjustments on a semi-adjustable articulator.
This study aims to advance the understanding of digital technologies in managing TMD, providing evidence for their efficacy in improving occlusal balance and minimizing enamel wear.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-40 years old
- •complete dentition
- •intact tooth
- •no occlusal disorder
- •stable jaw relation
- •No ongoing dental therapy, such as orthodontic or prosthodontics treatment.
排除标准
- •pregnant/lactating women
- •temporomandibular joint lesions found on clinical palpation or medical imaging examination
- •dentoalveolar pathology or ongoing treatment related to TMD
- •jaw opening less than 3 fingers
- •patients with occlusal dysfunctions
- •Patients with severe or moderate periodontitis.
- •Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.
- •Severe jaw functional limitations.
- •Removable dentures or partially dentate patients
- •Trauma of recent date towards face, head or neck
研究组 & 干预措施
Fully Digital Stabilization Splint (FD-SS)
Description:
Participants in this group will receive a stabilization splint fabricated using a fully digital workflow. The intervention includes:
- Intraoral scanning of the maxillary and mandibular arches to create a digital model.
- Jaw tracking using the Zebris JMA system to record mandibular movements.
- CAD design of the splint using Exocad software.
- Fabrication: 3D printing technology to manufacture the splint.
Purpose:
The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over a 6-month period.
Device Name: Fully Digital Stabilization Splint (FD-SS)
干预措施: stabilization splint (Device)
Conventional Stabilization Splint (C-SS)
Description:
Participants in this group will receive a stabilization splint fabricated using conventional methods. The intervention includes:
- Taking alginate impressions of the maxillary and mandibular arches to create plaster casts.
- Jaw registration using a Lucia jig and a semi-adjustable articulator for occlusal adjustment.
- Manual fabrication of the splint using polymethyl methacrylate (PMMA) resin.
Purpose:
The C-SS is designed to achieve occlusal stabilization and provide symptom relief for patients with temporomandibular disorders (TMD) over 6 months.
Device Name: Conventional Stabilization Splint (C-SS)
干预措施: stabilization splint (Device)
结局指标
主要结局
1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).
时间窗: 6 months
Occlusal Force Measurement: * Measured using OccluSense in Newtons (N)
次要结局
- Tooth Wear Measurement using an intraoral scanner(6 months)
研究者
Mohamed Sawi Mohamed
Dr
Minia University