A randomized clinical trial on innovative functional esthetic appliance for craniofacial growth modulation with 3D analysis of TMJ.

Background: The present study evaluated condylar position changes using cone beam computed tomography (CBCT) in treating Cl II malocclusion with the twin block and clear functional jaw corrector (CFJC) appliances.

Methods: In this RCT, we included 60 patients, with 30 in each treatment group (control group: twin block appliance, case group: CFJC appliance), randomly allocated using a lottery system. A twin block appliance or CFJC was fabricated for each patient following the protocol. Pre- and post-treatment records were collected over twelve months at 0-, 6- and 12-month intervals using cephalograms, CBCT, and questionnaires assessing the patient perception of the appliance.

Results: Both groups showed significant improvements in malocclusion. Cephalometric analysis showed statistically significant differences between the two groups in SNB, ANB, and U1-NA. In comparing the two groups, significant differences were found in Arnett's soft tissue parameters, including upper lip to E line, lower lip to E line, upper lip protrusion, upper lip length, lower lip length, lower 1/3 of the face, maxillary first incisor exposure, and mandibular height in the CFJC group. The intergroup comparison of projections to TVL (true vertical line) also showed significant differences across all parameters in the CFJC group. Furthermore, significant disparities in CBCT parameters were observed between the groups, specifically in condylar position, condylar height, and anterior joint space. Also, significant differences in patient comfort and perception of the appliance were observed, highlighting better compliance with the CFJC appliance.

Conclusion: The CFJC appliance is a top choice for Cl II malocclusion due to its superior effectiveness in skeletal, dental, and soft tissue improvements and significant condylar remodeling. Additionally, patients showed better compliance and acceptance of the CFJC appliance compared to traditional options, enhancing its clinical advantage in orthodontic practice.