背景:如今,用于治疗磨牙症和颞下颌关节紊乱病(TMD)的稳定夹板可以利用包括牙齿数字印模的数字工作流程来生产,数字夹板设计,和计算机辅助制造夹板。后者通常是一个铣削过程,然而,最近,3D打印由于其更好的成本和时间效率而受到欢迎。关于临床结果,3D打印的稳定夹板是否劣于铣削夹板仍然未知。
方法:该临床试验评估了3D打印咬合夹板与研磨咬合夹板相比的非劣效性,该试验是在具有两个队列的单中心前瞻性随机单盲交叉试验中进行的。一个队列包括20名磨牙症参与者,其他20名患有疼痛相关TMD的参与者,即,肌痛,肌筋膜疼痛,根据颞下颌疾病诊断标准(DC/TMD)诊断的颌骨肌肉/颞下颌关节的关节痛。密歇根型稳定夹板是在数字工作流程中通过使用CE标记的材料在其预期用途内进行铣削或3D打印来制造的。参与者按照随机顺序佩戴研磨和3D打印的夹板,每个夹板3个月。2周和3个月后随访。研究的结果参数是口腔健康影响概况(OHIP-G14)评估的口腔健康相关生活质量(OHRQoL),在视觉模拟量表上评估的参与者满意度,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佩戴和TMD组的疼痛/残疾减少,通过慢性疼痛分级量表(GCPSv2.0)评估,并按照DC/TMD标准进行临床评估,虽然技术结果措施夹板适合,磨损和断裂率。
结论:与碾磨的夹板相比,该试验将提供有关3D打印稳定夹板临床结果的重要信息,因此,支持或反对制造过程的循证决策。这个,反过来,将保证患者在夹板治疗期间的最大OHRQoL,治疗效果,和夹板的寿命。
背景:德国临床试验注册(DRKS)DRKS00033904。2024年3月15日注册。
BACKGROUND: 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.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: German Clinical Trials Register (DRKS) DRKS00033904. Registered on March 15, 2024.