Comparison of 3D-Printed Versus Analog Occlusal Splints on Patient-Reported Outcomes

Background: Occlusal splints are a widely used, reversible option for the management of temporomandibular disorders (TMD) and bruxism, and can now be produced either through conventional analog procedures or through fully digital additive workflows. Evidence on how patients actually perceive the two device types is scarce. Objective: To compare patient-reported outcomes (PROs)—pain, discomfort, perceived stability and adaptability—between 3D-printed and conventionally fabricated (analog) maxillary stabilization splints; the secondary aim was to compare chair time. Methods: In this randomized clinical trial, 28 adult patients requiring a maxillary Michigan-type stabilization splint were allocated by block randomization to a 3D-printed splint (intraoral scanning, CAD design, LCD printing with a flexible dimethacrylate resin, KeySplint Soft®) or to an analog splint (alginate impressions, self-polymerizing PMMA, Orthocryl®). PROs were rated on 0–10 numeric rating scales at delivery (T0), 1 month (T1) and 3 months (T2). Compliance, soft-tissue lesions and chair time were also recorded. Results: Twenty-five patients completed the follow-up (14 digital, 11 analog). Pain decreased significantly over time in both groups. The analog group reported significantly higher pain while wearing the splint (p = 0.019) and after removing it (p < 0.001), greater difficulty in removal (p < 0.001), higher maximum and average pain over the previous 30 days (p < 0.001), more soft-tissue pain (p = 0.009) and greater unpleasantness (p = 0.001). Perceived stability (p = 0.076) and chair time did not differ significantly, although occlusal adjustment at delivery was slightly shorter in the digital group. Compliance was higher with 3D-printed splints (p = 0.037), and no soft-tissue lesions were observed. Conclusions: Within the limitations of this trial, patients wearing 3D-printed splints reported less pain and discomfort and better acceptance than patients wearing analog splints, partially rejecting the null hypothesis. Differences in the manufacturing workflow and in the intrinsic properties of the two materials are the most plausible explanations and should be verified in larger trials including material characterization.