School and Hospital of Stomatology, Fujian Medical University,
Fuzhou, Fujian, 350000, China
NCT Number: NCT07345104
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.
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Interventional
Not applicable
Fuzhou, Fujian, 350000, China
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A custom-fabricated hard acrylic repositioning splint based on manual intraoral mandibular positioning. The splint is created by:
A custom-fabricated hard acrylic repositioning splint using adjustable articulator (Artex CR) methodology:
A digitally designed and 3D-printed repositioning splint using advanced digital workflow:
A digitally designed repositioning splint using electronic jaw motion tracking:
Time frame: Baseline and 3 months post-treatment
Quantitative assessment of changes in temporomandibular joint space using Cone Beam Computed Tomography (CBCT) with Ikeda's method.
Time frame: Baseline and 3 months post-treatment
Quantitative assessment of disc displacement using Magnetic Resonance Imaging (MRI) with angle measurement technique.
Fujian Medical University
Other
Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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