Application of fully digital occlusal splints in painful temporomandibular disorders: a randomized controlled clinical study.

OBJECTIVE

To evaluate the clinical efficacy of digital occlusal splints in alleviating pain and dysfunction in patients with temporomandibular disorders (TMD) and underlying mechanisms.

METHODS

TMD patients were enrolled and divided into digital and conventional occlusal splint groups (n = 66/group). Clinical outcomes, including visual analog scale (VAS) scores and temporomandibular function indices [Craniomandibular Index (CMI), Dysfunction Index (DI), Palpation Index (PI)], were assessed pre- and post-treatment. Cone-beam computed tomography (CBCT) was used to analyze condylar positional changes and joint space adaptation, while quantitative polymerase chain reaction and enzyme-linked immunosorbent assay measured serum levels of inflammatory markers. Correlations between clinical, structural, and biochemical parameters were examined.

RESULTS

Both groups exhibited significant post-treatment reductions in VAS scores, CMI, DI, and PI (P < 0.05), with the digital group demonstrating superior improvements in VAS, PI, and CMI compared to controls (P < 0.001). CBCT revealed favorable structural adaptations in both groups, though the digital group showed greater enhancements in glenoid fossa depth and medial joint space (P < 0.05). Biochemical analysis confirmed significant decreases in tumor necrosis factor-α (TNF-α), fibroblast growth factor receptor 3 (FGFR3), and nitric oxide synthase 2 (NOS2) levels, with additional reductions in nerve growth factor (NGF) and human leukocyte antigen B (HLA-B) observed exclusively in the digital group (P < 0.05).

CONCLUSION

Digital occlusal splints effectively mitigate TMD-related pain and dysfunction, likely through synergistic mechanisms involving occlusal stabilization, joint structural optimization, and inflammatory modulation. This technology represents a promising precision-based approach for personalized TMD management.