Digital Versus Conventional Stabilization Splints in Pain-related Temporomandibular Disorders: A Randomized Controlled Crossover Evaluation of Functional and Patient-centered Outcomes - A Pilot Study

Background: Temporomandibular disorders (TMDs) are multifactorial musculoskeletal conditions characterized by pain, muscle dysfunction, and occlusal imbalance. Stabilization splints (SS) remain integral to conservative management, while recent computer-aided design and manufacturing advances enable digitally fabricated splints with enhanced precision, comfort, and reproducibility. Objective: To compare the clinical efficacy of digitally fabricated and conventionally fabricated SS in patients with pain-related TMD using the randomized crossover design. Methods: Twenty-four patients (mean age: 29.4 ± 7.1 years) diagnosed with pain-related TMD were randomized into two treatment sequences (Digital → Conventional or Conventional → Digital). Each splint was worn for six weeks with a 3-week washout. Outcomes included pain intensity (Visual Analogue Scale), electromyographic (EMG) activity of the masseter and temporalis muscles, occlusal parameters (T-Scan), and oral health related quality of life using OHIP-14. Results: Both splints significantly reduced TMJ pain ( P < 0.001) and improved EMG parameters. Digital splints showed superior occlusal symmetry ( P = 0.041). OHIP-14 scores improved in both groups, correlating positively with pain reduction ( r = 0.58, P < 0.01). No significant carryover effects were detected. Conclusion: Both digital and conventional splints effectively reduced pain and enhanced neuromuscular function. Digital splints provided superior occlusal balance and precision, supporting their clinical integration in TMD management.