Patient Satisfaction and Occlusal Adjustments in Occlusal Splints Fabricated Using Fully Digital Versus Conventional Workflow in TMD Patients. (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Patient satisfaction
研究概览
简要总结
According to published literatures, the prevalence of TMD is approximately 10% in patients over 18 years of age with a considerable proportion being women of reproductive age. The treatment of TMD presents the following goals: decreasing joint and masticatory muscle pain, increasing the range of motion in the mandible, preventing degenerative changes in the articulating tissues. Management of TMD can be either conservative or surgical treatments, the conservative treatments include analgesia, medications, physical therapy, occlusal adjustment, splint therapy, localized steam application, and external muscle massage. The occlusal splint therapy is considered a common treatment option for TMD management. Flat stabilization splint is the preferred splint for such cases. It is designed to promote occlusal stability and decrease muscles tension by altering occlusion and allowing complete seating of the condyle in centric relation.
The evolution of digital technology created new era of dentistry that successfully digitalized the traditional workflow of occlusal splints including designing and manufacturing. Furthermore, virtual facebow and dynamic jaw relation record using jaw tracking device are another digital reward. The digital workflow can offer more predictable approach for occlusal splint construction, It could eliminate the traditional technical errors and enhance the occlusal accuracy
详细描述
The traditional workflow of occlusal splints includes, primary impression for both arches, pouring casts, patient deprogramming and centric jaw relation record followed by mounting. Then the occlusal splint is made out of a resin that includes wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint. After that, it is trimmed, polished, and seated back on the duplicate of the invested casts. It is a complicated process and time- consuming constructed followed by occlusal adjustments on the articulator. That traditional approach is time consuming and prone to many technical errors. Such errors are reflected in occlusal discrepancies that are considered critical for the effectiveness of occlusal splint therapy.
Recent advancements in the field of intra-oral scanning (IOS), jaw tracking device for digitally recording the maxillomandibular relationship, maximum intercuspation, centric occlusion and the patient's mandibular motion. This technique incorporates the mandibular motion into the 3-dimensional (3D) virtual patient representation to integrate the 3D dynamic virtual patient visualization and computer-aided design/computer-aided manufacturing (CAD/CAM) may have the potential to compensate for some of the shortcomings of conventional splint therapy and deliver improved clinical results, while simplifying the workflow. Several studies have shown the improved quality and material properties of CAD/CAM splints in comparison to conventional ones, but little of them reported fully digital workflow starting from scanning of maxillary and mandibular teeth, using jaw tracking device to obtain personalized condylar motion parameters and individualized maxillary position to better simulate the actual movement of the patient in the laboratory (Revilla, Marta etal,2022) and Computer-aided design/computer-aided manufacturing (CAD/CAM) in final production of occlusal splints all of these fully digital steps may be possibly reducing the adjustment time for occlusal devices and achieving predictable efficacy.
This study aims to compare the difference, if present in patient satisfaction and the amount of occlusal adjustments in occlusal splints fabricated using fully digital versus conventional workflow.
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
- Single (Outcomes Assessor)
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.
- •Normal jaw opening.
- •Intact teeth.
- •No ongoing dental therapy, such as orthodontic or prosthodontic treatment.
- •TMD patients with more than one of following symptoms or signs: myofascial pain and /or pain in the TMJ, myofascial pain and/or pain in the TMJ on palpation, muscles tenderness, headache or earache.
- •Patients who had unsuccessfully undergone splint therapy or other TMD treatments in the past were not excluded.
排除标准
- •Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, osteoporosis, and patients taking analgesic, muscle relaxant, or anti inflammatory drugs were excluded because such drugs could influence the results.
- •Temporomandibular joint lesions found on clinical palpation or medical imaging examination.
- •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.
研究组 & 干预措施
Occlusal splints manufactured with Conventional workflow
For the comparator group, maxillary and mandibular impressions will be made with alginate impression material, models will be poured with gypsum, facebow (Bio-art) record and interocclusal registrations will be recorded at centric by using bite registration material after patient deprogramming with Lucia jig. The models will be mounted in a semi-adjustable articulator, wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint
干预措施: Occlusal splints manufactured with Conventional workflow (Device)
Occlusal splints manufactured with fully digital workflow
The intervention involves the fabrication of 3D printing of occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic) utilizing printable resin material
干预措施: Occlusal splints manufactured with fully digital workflow. (Device)
结局指标
主要结局
Patient satisfaction
时间窗: '' Up to 12 weeks''
Primary outcome: patient satisfaction will be recorded using Numeric scales (TMD/NS, 10 cm), this questionnaire includes the following aspects; headaches, face pain, jaw joint pain, jaw joint noises, mastication pain, neck pain, face tension, limitation of mouth opening, complaints during mastication, and teeth sensitivity at baseline and then after 1 and 3 months. The questioner was translated into Arabic language to be understood by the patients.
次要结局
- Amount of occlusal adjustments(Base line or day 1)
研究者
Hadeer Abdelhadi
Teacher assistant
Cairo University