Background: Temporomandibular disorder (TMD) is a grouping of heterogeneous disorders with multifactorial origins. Stabilization splints (SS) have demonstrated an acceptable treatment effect in TMD. The possible changes at the skeletal, dental, and soft tissue levels need to be addressed to evaluate the benefit/risk ratio of this therapeutic procedure. Accordingly, this study aimed to three‑dimensionally evaluate skeletal, dentoalveolar and soft tissue changes after SS treatment for patients with TMD.

Methods: This retrospective study included 74 adult patients with myofascial and/or intra-articular disorders (25 males and 49 females), with an average age of 22.88 ± 4.8 years, who underwent SS treatment. Pre- and post-treatment Cone beam computed tomography were analysed using Invivo 6.0.3 software. The primary outcome was the vertical skeletal and dentoalveolar changes, while the secondary outcomes were the anteroposterior skeletal, dentoalveolar and soft tissue changes. Paired t-test and Wilcoxon rank sum test were used for statistical analyses.

Results: For the primary outcome; skeletally, there was a significant increase in mandibular plane inclination (difference: 0.82°±1.37), decrease facial height ratio (difference: 0.45%±1.07) and at the dentoalveolar level, the inclination of the functional (FOP-SN, FOP-FH) and bisecting (BOP-SN, BOP-FH) occlusal planes exhibited a significant increase too (difference: 0.38 ± 1.43°, 0.49 ± 1.62°, 0.44 ± 1.29° and 0.41 ± 1.17°, respectively) and also a decrease in the overbite (difference: -0.54 ± 0.83). For the secondary outcomes; there was a significant decrease in mandibular position (SNB) (difference: 1.60 ± 1.36°) and increase in the overjet (difference: 0.93 ± 1.04, p < 0.001) and a significant lower lip retrusion (difference: 0.33 ± 1.01 mm p < 0.01), was observed too.

Conclusions: SS therapy resulted in significant vertical skeletal and dentoalveolar changes that were manifested mainly by facial height ratio, mandibular and occlusal plane changes, and to a lesser extent, significant anteroposterior skeletal, dentoalveolar, and soft tissue changes in the form of mandibular position, increased overjet and a more retrusive lower lip. These changes should be considered during patients' selection prior to initiating SS therapy.