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临床试验/NCT07477873
NCT07477873Enrolling By Invitation不适用

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

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Change in Temporomandibular Joint (TMJ) Anatomical Structures After Orthognathic Surgery

研究概览

简要总结

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.

详细描述

Orthognathic surgery is the surgical treatment of one or both jaws by osteotomy of the bones in order to correct the malalignment/abnormal shape of the jaws, to restore their relationship to the central occlusion, thus restoring a correct bite and restoring the correct facial shape.

Individuals with dentofacial abnormalities struggle with biting and chewing, social interactions, and peer pressure to alter their look. Due to these difficulties, these people may suffer from psychological issues and see a marked decline in their quality of life.

Orthognathic surgery is a specialized procedure that must be carried out with orthodontic treatment. This means that before and after the surgical intervention, orthodontic care is essential to align the teeth and jaws, ensuring optimal results properly. The combination of these treatments helps correct misalignments, improve bite function, and enhance facial aesthetics. Without orthodontic preparation and follow-up, the surgical correction alone would not be as effective in achieving a stable and harmonious outcome.

Conventional approach

The term "orthodontic first approach" refers to the conventional method used in treatment, where orthodontic procedures are initiated before any surgical intervention. To achieve a stable surgical occlusion and overcome postoperative occlusal instability, preoperative orthodontic therapy is carried out before orthognathic surgery to realign the maxilla and mandible and to disclose the true skeletal disparity before surgery. The attractive profile of the face and the function of the teeth gradually deteriorate throughout the preoperative phase due to dental decompensation. Preoperative orthodontic therapy has the major disadvantage of being time-consuming. It typically takes 12 to 24 months, but depending on the complexity of the patient's initial oral condition, it may take up to 48 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients treated at the Lithuanian University of Health Sciences (LSMU) Kaunas Clinics Department of Maxillofacial Surgery.
  • Diagnosed according to the internal registry of Kaunas Clinics with one of the following ICD-10 codes:
  • K07.0 - Major abnormalities of jaw size K07.1 - Abnormalities of jaw-cranial base relationship K07.2 - Abnormalities of dental arch relationship K07.4 - Malocclusion, unspecified K07.5 - Functional disorders of teeth and face K07.8 - Other dentofacial anomalies K07.9 - Dentofacial anomaly, unspecified
  • Scheduled to undergo planned orthognathic surgery.
  • Classified as American Society of Anesthesiologists (ASA) physical status I or II.
  • Age ≥ 18 years.
  • Able and willing to provide written informed consent.

排除标准

  • Refusal or inability to provide informed consent.
  • Planned orthognathic surgery combined with additional elective surgical procedures (e.g., rhinoplasty, blepharoplasty, or other cosmetic procedures).
  • Age under 18 years.
  • Reinterventions or revision orthognathic surgery.
  • Emergency surgical procedures.
  • Known allergy to local anesthetics, anti-inflammatory drugs, or opioids.
  • Diagnosed anxiety and/or depression requiring pharmacological treatment.
  • Presence of psychiatric disorders classified under ICD-10 Chapter F (Mental and Behavioral Disorders).
  • Pregnancy.

研究组 & 干预措施

Bimaxillary Orthognathic Surgery Patients

Experimental

Patients undergoing planned orthognathic surgery (with or without genioplasty) with preoperative and postoperative functional, anatomical, and psychological assessment.

干预措施: Observational Assessment (Other)

结局指标

主要结局

Change in Temporomandibular Joint (TMJ) Anatomical Structures After Orthognathic Surgery

时间窗: Baseline (1 day before surgery) and 3-6 months after surgery

Assessment of preoperative and postoperative changes in temporomandibular joint anatomical structures using cone-beam computed tomography (CBCT), including evaluation of condylar position and joint space measurements.

次要结局

  • Change in Masseter Muscle Strength After Orthognathic Surgery(Baseline and 3-6 months after surgery)
  • Change in Depression and Anxiety Symptoms(Baseline and 3-6 months after surgery)
  • Change in Emotional Response Measured by iMotions Platform(Baseline and 3-6 months after surgery)
  • Change in Facial Pain Intensity(Baseline and immediate postoperative period)
  • Change in Sleep Quality After Orthognathic Surgery(Baseline and 3-6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zygimantas Petronis

Oral surgeon, PhD student

Lithuanian University of Health Sciences

研究点 (1)

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