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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.
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:
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:
Assessment Methods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoral Direct Positioning | Active Comparator | 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. |
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| Articulator Positioning | Experimental | 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. |
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| Digital Anatomical Positioning | Experimental | 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. |
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| Digital Jaw Motion Tracking | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Clicking Elimination Repositioning Splint | Device | A custom-fabricated hard acrylic repositioning splint based on manual intraoral mandibular positioning. The splint is created by:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Temporomandibular Joint Space Ratio | Quantitative assessment of changes in temporomandibular joint space using Cone Beam Computed Tomography (CBCT) with Ikeda's method. | Baseline and 3 months post-treatment |
| Change in Disc-Condyle Relationship Angle | Quantitative assessment of disc displacement using Magnetic Resonance Imaging (MRI) with angle measurement technique. | Baseline and 3 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School and Hospital of Stomatology, Fujian Medical University, | Fuzhou | Fujian | 350000 | China |
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Participants are assigned to one of four parallel groups based on patient preference and clinical feasibility (non-randomized allocation):
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Blinding and Masking Procedures:
Outcome Assessor Blinding
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
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.
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| Adjustable Articulator Repositioning Splint | Device | A custom-fabricated hard acrylic repositioning splint using adjustable articulator (Artex CR) methodology:
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| CAD-Designed Anatomical Repositioning Splint | Device | A digitally designed and 3D-printed repositioning splint using advanced digital workflow:
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| Electronic Jaw Tracking Repositioning Splint | Device | A digitally designed repositioning splint using electronic jaw motion tracking:
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