Parallel Randomized Controlled Clinical Trial in Patients with Temporomandibular Disorders Treated with a CAD/CAM Versus a Conventional Stabilization Splint.

Abstract

This parallel randomized controlled trial (RCT) compared the efficacy of a computer-aided design/computer-assisted manufacture (CAD/CAM) splint versus a conventional stabilization splint in patients with temporomandibular disorders (TMD). A sample of 48 age-matched TMD patients from the Ludwig Maximilian University Prosthodontic Department in Munich, Germany, were randomly allocated into groups 1 (CAD/CAM splint) and 2 (conventional splint). The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) was used for TMD Axis I (groups I, II, and III) and Axis II (chronic pain grade [CPG]) diagnoses. Numeric scales (TMD/NS, 10 cm) were used to measure headaches, face pain, jaw joint pain, jaw joint noises, mastication pain, neck pain, face tension, limitation of mouth opening, complaints during mastication, and teeth sensitivity at baseline and then monthly for 9 months (T₁ to T₁₀). Optical axiography was used to measure right and left condyle movements (mm) at baseline, 3 months, and 6 months (T₁, T₄, and T₇). A total of 32 patients (drop-out rate = 33%; 68.75% women; 28.51 ± 7.13 years old), 16 per group, completed the study. RDC/TMD Axis I showed the following diagnoses: 93.75% muscle disorders, 37.75% disc displacement with reduction, 3.12% disc displacement without reduction, and 56.25% arthralgia. There was a significant reduction in 10 out of 13 items of the TMD/NS in the CAD/CAM splint versus 8 out of 13 in the conventional splint. However, no significant improvement in mandibular movements (ie, increase in range of motion and reduction in asymmetry between right and left condyles) was observed. Both treatments were equally efficacious and no difference was found between them.