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Abstract
Background: This systematic review aims to assess the effectiveness of 3D occlusal splints (OS) for managing pain and improving maximum mouth opening in temporomandibular joint disorders (TMDs) via randomized controlled trials (RCTs). Materials and Methods: Searches were conducted in PUBMED, SCOPUS, and the COCHRANE library. Eligible studies were evaluated for risk of bias (RoB) by two reviewers based on predetermined criteria: generation of random sequences, implementation of single-operator protocol, inclusion of a control group, blinding of testing machine operator, uniformity in sample preparation, evaluation of failure modes, adherence to manufacturer's instructions for materials, and explanation of sample size calculation. If the author provided information about the examined parameter, the study was categorized as having a "YES." Conversely, if the information was absent, the parameter was marked as "NO." The RoB for each study was then determined according to the total number of "YES" responses: 1 to 3 indicated a high RoB, 4-6 signified a medium risk, and 7 to 8 indicated low RoB. Out of 14 articles, 5 RCTs underwent qualitative analysis. Results: Results indicate that OS therapy effectively manages TMD-related pain and reduces TMJ clicking. Additionally, it improves mouth opening in patients with initial limitations. Better symptom management correlates with improved quality of life in TMD sufferers. Conclusions: Further comparative clinical trials are necessary due to remaining uncertainties regarding how specific OS design and fabrication methods may impact TMD outcomes.
