Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Temporomandibular Joint Space Ratio
研究概览
简要总结
This study evaluates a new, individualized treatment for adolescents with temporomandibular joint disorders (TMD) caused by bilateral, reducible disc displacement. Participants will undergo clinical and imaging examinations, including cone-beam CT (CBCT), MRI, and intraoral digital scanning to create three-dimensional models of the teeth and jaw. Based on these data, the study team will design and fabricate a personalized repositioning digital occlusal splint for each participant. Patients will be instructed on how to wear the splint and will return for regular follow-up visits to monitor symptoms and adjust the splint as needed. The study aims to improve pain, chewing function, and overall quality of life. All research-related imaging, digital scans, splint fabrication, and follow-up visits will be provided at no cost to participants. Possible risks include temporary discomfort or pressure when first wearing the splint, and the possibility that symptoms may not improve as expected. Participant safety, privacy, and data confidentiality will be strictly protected, and participants may withdraw from the study at any time without affecting their future medical care.
详细描述
Detailed Description This study evaluates four different methods for mandibular repositioning in patients with bilateral reducible temporomandibular joint (TMJ) disc displacement requiring occlusal reconstruction.
Methods of Mandibular Repositioning:
- Intraoral Direct Positioning Group: The therapeutic jaw position is determined clinically using the clicking elimination method, where patients open wide until clicking occurs, then gradually retract the mandible while performing opening-closing movements to find the minimal protrusion position without clicking.
- Articulator Positioning Group: Uses mechanical facebow transfer and semi-adjustable articulator (Artex CR) with condylar guidance parameters obtained from protrusive and lateral excursion records. The therapeutic position is determined by analyzing CBCT joint space measurements and MRI disc displacement data.
- Digital Anatomical Positioning Group: Combines intraoral scanning data with CBCT-reconstructed 3D jaw models. The therapeutic position is determined by referencing MRI disc reduction phase, optimal joint space ratios, and anatomical landmarks using CAD software (Exocad).
- Digital Jaw Motion Tracking Group: Integrates 3D jaw models with electronic jaw tracking data (Zebris). The therapeutic position is determined by analyzing condylar movement trajectories (identifying the "figure-8" pattern crossover points indicating disc displacement) combined with dynamic MRI and optimal joint space parameters.
Treatment Protocol: All groups receive digitally designed and manufactured repositioning splints. Patients wear splints 24 hours daily (except during meals) for 3 months, with follow-up adjustments at 2 weeks, 1 month, 2 months, and 3 months.
Imaging Protocol:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding and Masking Procedures:
- Outcome Assessor Blinding
- All clinical and radiographic outcome measurements will be performed by independent assessors who are unaware of the participant's group allocation.
- Participants will be assigned unique, randomly generated identification codes that do not reveal group assignment.
- Radiographic images (CBCT and MRI) will be anonymized and presented in a randomized order to blinded radiologists.
- Limitations of Masking
o Complete blinding is not possible due to the distinct nature of interventional approaches: a) Participants will be aware of their specific mandibular repositioning technique b) Clinicians performing interventions cannot be blinded due to different positioning methods 3. Blinding Process for Outcome Assessment o Clinical outcome measures (Craniomandibular Index, Joint Movement Assessment) will be evaluated by a research assistant not involved in the intervention.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of reducible temporomandibular joint (TMJ) disc displacement according to the 2014 revised criteria of the International Association for Dental Research;
- •Bilateral reducible disc displacement confirmed by MRI;
- •Reproducible joint clicking during mandibular opening and closing;
- •Permanent dentition with full cognitive and communicative ability;
- •Signed informed consent with good treatment compliance.
排除标准
- •Non-reducible disc displacement, osteoarthrosis, isolated myofascial pain, or other conditions not meeting diagnostic criteria;
- •Receipt of other TMJ disorder treatments within the past 3 months;
- •Presence of systemic diseases, psychiatric disorders, or impaired consciousness.
研究组 & 干预措施
Intraoral Direct Positioning
Therapeutic mandibular position is determined using the clinical clicking elimination method. Patients perform wide opening until clicking occurs, then gradually retract the mandible while making opening-closing movements to identify the minimal protrusion position without clicking. A repositioning splint is fabricated based on this position.
干预措施: Clinical Clicking Elimination Repositioning Splint (Device)
Articulator Positioning
Therapeutic mandibular position is determined using a semi-adjustable articulator (Artex CR) with mechanical facebow transfer. Condylar guidance angles are obtained from protrusive and lateral excursion records. The optimal position is calculated based on CBCT joint space measurements and MRI disc displacement data. A repositioning splint is fabricated accordingly.
干预措施: Adjustable Articulator Repositioning Splint (Device)
Digital Anatomical Positioning
Therapeutic mandibular position is determined by integrating intraoral scanning data with CBCT-reconstructed 3D jaw models using CAD software (Exocad). The optimal position is calculated by referencing MRI disc reduction phase, ideal joint space ratios (anterior:superior:posterior = 1:1.3:1), and anatomical landmarks. A repositioning splint is digitally designed and 3D-printed.
干预措施: CAD-Designed Anatomical Repositioning Splint (Device)
Digital Jaw Motion Tracking
Therapeutic mandibular position is determined by integrating 3D jaw models with electronic jaw tracking data (Zebris JMA system). The optimal position is identified by analyzing condylar movement trajectories, specifically locating the crossover points of the "figure-8" pattern indicating disc displacement, combined with dynamic MRI and joint space parameters. A repositioning splint is digitally designed and 3D-printed.
干预措施: Electronic Jaw Tracking Repositioning Splint (Device)
结局指标
主要结局
Change in Temporomandibular Joint Space Ratio
时间窗: Baseline and 3 months post-treatment
Quantitative assessment of changes in temporomandibular joint space using Cone Beam Computed Tomography (CBCT) with Ikeda's method.
Change in Disc-Condyle Relationship Angle
时间窗: Baseline and 3 months post-treatment
Quantitative assessment of disc displacement using Magnetic Resonance Imaging (MRI) with angle measurement technique.
次要结局
未报告次要终点
研究者
Hao Yu
Associate Professor & Associate Dean, Dept. of Prosthodontics, Fujian Medical University; Adjunct Associate Professor, Dept. of Applied Prosthodontics, Nagasaki University, Nagasaki, Japan.
Fujian Medical University