Fully digital workflow versus conventional methods for fabricating the Michigan appliance in patients with temporomandibular joint disorder. A randomized controlled clinical trial

Abstract

OBJECTIVE: Fabrication of occlusal stabilization splints using fully digital workflow is feasible with several advantages over conventional workflow, including easy accessibility, time efficiency, and high accuracy in splint quality. Accordingly, the study's aimed to evaluate the effect of fully digital fabricated occlusal splints on patient-centered outcomes compared to traditionally manufactured splints. MATERIALS AND METHODS: This is a prospective, randomized, blind study included 70 participants (35 in each group) with temporomandibular disorder (TMD) for which Michigan occlusal splint therapy was indicated. Group I participants received hard acrylic Michigan- splint fabricated using a fully digital workflow; while Group II participants received an identical Michigan splint fabricated using the conventional workflow. Pain intensity, maximum mouth opening (MMO), and oral health-related quality of life were assessed preoperatively and at 1, 3, and 6 months after the splint delivery. RESULTS: Group I demonstrated a significantly lower pain scores and greater MMO compared to Group II (p ≤ 0.001) at the 1- and 3-months assessments. By the 6-months follow-up, pain scores were no longer significantly different between groups (p = 0.177). In contrast, the advantage for Group I in MMO remained statistically significant in 6 months (p = 0.001). Regarding to OHIP-14 total score, Group I reported better scores at all follow-up points (p ≤ 0.001). Additionally, the digital workflow significantly reduced treatment time (p < 0.001) and number of clinical visits(p < 0.001). CONCLUSION: A fully digital workflow for fabricating Michigan stabilization splints offers significant advantages in treatment efficiency and early clinical outcomes. However, both digital and conventional workflows demonstrated comparable long-term effectiveness in pain control.