Background <p>The Kovacs digital splint is a new approach for treating temporomandibular disorders (TMD), but comparative studies on its clinical efficacy versus traditional occlusal splints are still lacking.</p> Materials and methods <p>Patients from three centers were randomly assigned to the experimental group (Kovacs digital splint, KDS) or the control group (soft splint, SS). Pain, mouth opening, and clicking before treatment (T0), after 14 ± 5 days (T1), and 35 ± 5 days (T2) treatment were evaluated. The effective rate of symptoms improvement between the two groups and subgroups including gender, age, disease stage, and symptom types were compared.</p> Results <p>A total of 264 patients were included. Both groups showed significant improvement in pain, mouth opening, and clicking after treatment (<i>P</i> &lt; 0.05). The KDS group had a higher overall effective rate than the SS group (61.1% vs. 47.5%, <i>P</i> &lt; 0.025). In patients aged over 40 years and with normal condylar relationships who had myogenous pain, the effective rates of KDS were significantly higher than SS (<i>P</i> &lt; 0.05).</p> Conclusion <p>The clinical efficacy of KDS for treating TMD was superior to SS, especially for myogenous TMD.</p> Trial registration <p>ID: ChiCTR2200064940, Date of Registration: 10/24/2022.</p>