Department of Prosthetic Dentistry, Center for Dental Medicine, Medical Center ‑ University of Freiburg, Faculty of Medicine, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.
Institute of Medical Biometry and Statistics, Medical Center ‑ University of Freiburg, Faculty of Medicine, University of Freiburg, Stefan-Meier-Str. 26, Freiburg, 79104, Germany.
Trials. 2024 Sep 5;25(1):589. doi: 10.1186/s13063-024-08437-7.
Nowadays, stabilization splints for the management of bruxism and temporomandibular disorders (TMD) can be produced utilizing a digital workflow comprising a digital impression of the teeth, digital splint design, and computer-aided manufacturing of the splints. The latter is usually a milling process, however, more recently 3D printing gained popularity due to its better cost and time efficiency. It remains unknown whether 3D printed stabilization splints are inferior to milled splints regarding clinical outcomes.
This clinical trial assesses the non-inferiority of 3D printed occlusal splints compared to milled occlusal splints in a monocentric prospective randomized single-blinded crossover trial with two cohorts. One cohort includes 20 participants with bruxism, the other 20 participants with pain-related TMD, i.e., myalgia, myofascial pain, or arthralgia of the jaw muscles/the temporomandibular joint(s) diagnosed according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Michigan-type stabilization splints are fabricated in a digital workflow by milling or 3D printing using CE-marked materials within their intended purpose. The participants wear a milled and a 3D printed splint in a randomized order for 3 months each, with follow-up visits after 2 weeks and 3 months. Investigated outcome parameters are oral health-related quality of life (OHRQoL) evaluated by the Oral Health Impact Profile (OHIP-G14), participant satisfaction as rated on a visual analog scale, therapeutic efficacy, and technical result of the splints. In this context, therapeutic efficacy means antagonist wear and-in the TMD group-reduction of pain/disability assessed by the Graded Chronic Pain Scale (GCPS v2.0) and clinical assessment following the DC/TMD standard, while technical outcome measures splint fit, wear and fracture rate.
The trial will provide important information on the clinical outcome of 3D printed stabilization splints in comparison to milled splints and will, therefore, enable an evidence-based decision in favor of or against a manufacturing process. This, in turn, will guarantee for a maximum of the patient's OHRQoL during splint therapy, therapeutic efficacy, and longevity of the splints.
German Clinical Trials Register (DRKS) DRKS00033904. Registered on March 15, 2024.
如今，磨牙症和颞下颌关节紊乱病（TMD）的管理可采用数字化工作流程来制作稳定夹板，该流程包括牙齿的数字印模、数字夹板设计以及夹板的计算机辅助制造。后者通常是铣削工艺，但最近由于成本和时间效率更高，3D 打印技术越来越受欢迎。目前尚不清楚 3D 打印的稳定夹板在临床结果方面是否逊于铣削夹板。
本临床试验评估了在一项中心前瞻性随机单盲交叉试验中，3D 打印咬合夹板与铣削咬合夹板的非劣效性，该试验分为两个队列。一个队列包括 20 名磨牙症患者，另一个队列包括 20 名疼痛相关 TMD 患者，即根据颞下颌关节紊乱病诊断标准（DC/TMD）诊断的咀嚼肌/颞下颌关节肌肉疼痛、肌筋膜疼痛或关节痛。密歇根型稳定夹板通过铣削或使用符合 CE 标志的材料的 3D 打印在数字工作流程中制造，用于其预期目的。参与者以随机顺序佩戴铣削和 3D 打印夹板，每个夹板佩戴 3 个月，在 2 周和 3 个月后进行随访。研究的结果参数是通过口腔健康影响简表（OHIP-G14）评估的口腔健康相关生活质量（OHRQoL）、参与者在视觉模拟量表上的满意度、治疗效果和夹板的技术结果。在这种情况下，治疗效果是指拮抗剂的佩戴情况，在 TMD 组中，疼痛/残疾程度的降低是通过慢性疼痛分级量表（GCPS v2.0）和根据 DC/TMD 标准进行的临床评估来评估的，而技术结果测量夹板的贴合度、佩戴和断裂率。
该试验将提供关于 3D 打印稳定夹板与铣削夹板相比的临床结果的重要信息，从而可以根据制造工艺做出有利或不利的循证决策。这反过来又将保证在夹板治疗期间最大限度地提高患者的 OHRQoL、治疗效果和夹板的耐用性。
德国临床试验注册处（DRKS）DRKS00033904。于 2024 年 3 月 15 日注册。
