Clinical Research Directory

Evaluation of Emotional Responses Using the I-Motions System and Self-assessment Questionnaires, and Assessment of Postoperative Anatomical and Structural Units (TMJ and Masticatory Muscles) in Orthognathic Surgery Patients

Orthognathic surgery is a surgical procedure involving one or both jaws to correct skeletal discrepancies, restore proper occlusion, and improve facial aesthetics. Individuals with dentofacial abnormalities often experience difficulties with chewing, biting, and social interaction, which may negatively impact psychological well-being and overall quality of life. Orthognathic surgery must be combined with orthodontic treatment before and after the operation to ensure optimal functional and aesthetic outcomes. The conventional "orthodontics-first" approach involves prolonged preoperative orthodontic treatment (typically 12-24 months, sometimes up to 48 months) to decompensate dental alignment and reveal the true skeletal discrepancy prior to surgery. Although effective for achieving stable occlusion, this method is time-consuming and may temporarily worsen facial aesthetics and function during the preoperative phase. The "surgery-first" approach eliminates or significantly reduces preoperative orthodontics, performing surgery first followed by postoperative orthodontic treatment. This method shortens overall treatment time, provides immediate aesthetic improvement, facilitates favorable orthodontic tooth movement, and may lead to earlier improvement in conditions such as obstructive sleep apnea. It is generally recommended for patients with mild anterior crowding, minimal transverse discrepancies, a flat or mild curve of Spee, and normally inclined incisors. Common surgical techniques include genioplasty, bilateral sagittal split osteotomy (BSSO), oblique ramus osteotomy, and Le Fort I osteotomy. Whenever possible, procedures are performed intraorally to avoid visible scarring. Orthognathic surgery induces not only anatomical and functional changes but also psychological adaptations. Soft tissues, masticatory muscles, and the temporomandibular joint (TMJ) adapt to new skeletal relationships, contributing to improved facial balance and patient self-perception. However, there is currently no unified diagnostic algorithm to comprehensively evaluate postoperative anatomical, physiological, and socio-emotional changes. Emotional satisfaction, TMJ structural changes, muscle strength variations, sleep quality, and pain outcomes remain insufficiently studied. The study proposes two hypotheses: the null hypothesis (H0) assumes no postoperative changes in TMJ anatomy, masticatory muscle strength, emotional response, facial pain, sleep quality, or depressive characteristics; the alternative hypothesis (H1) assumes that such changes do occur. The objectives are to evaluate masticatory muscle strength and structure, TMJ anatomical changes, emotional state, depression and anxiety predisposition, sleep quality, facial pain, and aesthetic perception before and after surgery. The study will include up to 100 patients undergoing bimaxillary orthognathic surgery (with or without genioplasty) at the Lithuanian University of Health Sciences Kaunas Clinics. Assessments will be conducted preoperatively, immediately postoperatively, and 3-6 months after surgery. Methods include CBCT imaging for TMJ evaluation, electromyography for masseter muscle strength, emotional analysis using the iMotions platform (facial expression analysis and electrodermal activity), and validated questionnaires (PHQ-15, HADS, VAS). Strict ethical standards will be followed in accordance with international guidelines, with informed consent obtained from all participants. No additional financial costs or conflicts of interest are declared. The expected outcome is to determine correlations between anatomical, functional, psychological, and aesthetic changes following orthognathic surgery, providing a more comprehensive understanding of patient satisfaction and overall quality-of-life improvement.

Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction

To study the effect vitamin D effect on orthodontic tooth movement when used in combination with coticision technique, independent t test or an equivalent non-parametric test will be used for comparison. According to a previous study by (S. T. Varughese, et al. (2019) , "Effect of vitamin D on canine distalization and alveolar bone density using multi-slice spiral CT: a randomized controlled trial

Effects of Vitamin D in Patients Undergoing Fixed Orthodontic Mechanotherapy

The goal of this interventional research is to determine the impact of vitamin D intake on substances in saliva, pain, tooth movement, and the density of the bone around teeth in patients during orthodontic treatment. It will compare the effects of vitamin D supplementation with a placebo to clarify its role in the aforementioned aspects of orthodontic care. The main questions it aims to answer are: How does vitamin D supplementation affect salivary opiorphin levels in patients undergoing fixed orthodontic mechanotherapy at Specialist Hospital Universiti Sains Malaysia? What is the impact of vitamin D supplementation on pain perception during fixed orthodontic mechanotherapy? How does vitamin D supplementation influence the rate and quality of tooth movement in patients undergoing fixed orthodontic mechanotherapy? What is the relationship between salivary opiorphin levels and pain perception in patients supplemented with vitamin D during fixed orthodontic mechanotherapy? How does vitamin D supplementation affect changes in alveolar bone density during fixed orthodontic mechanotherapy? Researchers will provide vitamin D to the experimental group while the control group receives a placebo to see if vitamin D intake has an impact on substances in saliva, pain, tooth movement, and the density of the bone around teeth during orthodontic treatment. Participants will: Take vitamin D or a placebo every day for 4 months Visit the clinic once every 4 weeks for checkups and tests Participate in the study for a duration of up to 4 months

Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars

This study aims to evaluate the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar) will be recruited.. Using a split-mouth design, one side will receive the intervention (auxiliary segmental lingual appliances), while the other side will serve as the control. The variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. Measurements will be taken on digital impressions at baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after applying the auxiliary segmental lingual appliances. The effectiveness will be assessed by comparing the two groups.

Microanalysis of Changes in 3D Geometry of Orthodontic Mini-implants

The orthodontic mini-implants used in the study are temporary screws inserted into the bone to provide anchorage for challenging tooth movements that could not be carried out using the patient's own teeth. They are made of a medical grade titanium alloy (Ti6Al4Va), with a length of 8 mm and a diameter of 1.3 mm. After the completion of the treatment phase requiring specific anchorage, they are removed and disposed of as a medical waste. The insertion of the mini-screw is conditioned by the individual treatment plan and the treatment protocol would not differ from the standard treatment. The aim of the project is to analyze changes in the macrogeometry and wear of the surfaces of retrieved orthodontic micro-implants after their clinical use. Upon completion of clinical tasks, the mini-screws will be removed and retrieved for laboratory phase of the study. The laboratory phase will consist of: microscopic and profilometric examinations, as well as scanning before insertion and after removal of the mini-implants, and a clinical phase: the use of previously scanned and sterilized mini-implants in patients participating in the study.

Hyrax Vs. Invisalign Palatal Expander Clinical Study

The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.