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

NCT07477873 | Enrolling By Invitation

• 1 other identifier: BE-2-133
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthognathic Surgery; Malocclusions; Jaw Abnormalities; Dentofacial Deformities; Temporomandibular Joint; Masticatory Muscles; Sleep Quality; Anxiety

Keywords

Orthognathic surgery; Dentofacial deformities; Bimaxillary surgery; Temporomandibular joint (TMJ); Masticatory muscle strength; Masseter electromyography; Depression and anxiety; Hospital Anxiety and Depression Scale (HADS); Quality of life; Visual Analogue Scale (VAS); iMotions platform

Outcome Measures

Primary Outcomes (1)

• Change in Temporomandibular Joint (TMJ) Anatomical Structures After Orthognathic 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.

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

Secondary Outcomes (5)

• 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

Study Arms (1)

Bimaxillary Orthognathic Surgery Patients

EXPERIMENTAL

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

Other: Observational Assessment

Interventions

Observational Assessment OTHER

Prospective assessment of anatomical, functional, and psychological changes before and after standard orthognathic surgery.

Bimaxillary Orthognathic Surgery Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences, Departments of maxillofacial surgery, Kaunas Clinics

Kaunas, Kauno, 50161, Lithuania

Location

Related Publications (10)

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

  PMID: 24141714 BACKGROUND

• Tiret L, Hatton F, Desmonts JM, Vourc'h G. Prediction of outcome of anaesthesia in patients over 40 years: a multifactorial risk index. Stat Med 1988; 7: 947-54

  BACKGROUND

• Kazuhiro Yamada, Kooji Hanada, Takafumi Hayashi, Jusuke. Condylar bony change, disk displacement, and signs and symptoms of TMJ disorders in orthognathic surgery patients. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology. Volume 91, Issue 5, May 2001, Pages 603-610.

  BACKGROUND

• Ruggiero F, Borghi A, Bevini M, Badiali G, Lunari O, Dunaway D, Marchetti C. Soft tissue prediction in orthognathic surgery: Improving accuracy by means of anatomical details. PLoS One. 2023 Nov 27;18(11):e0294640. doi: 10.1371/journal.pone.0294640. PMID: 38011187; PMCID: PMC10681161.

  BACKGROUND

• Mazzaferro DM, Wes AM, Naran S, Pearl R, Bartlett SP, Taylor JA. Orthognathic Surgery Has a Significant Effect on Perceived Personality Traits and Emotional Expressions. Plast Reconstr Surg. 2017 Nov;140(5):971-981. doi: 10.1097/PRS.0000000000003760. PMID: 29068935.

  BACKGROUND

• Monson LA. Bilateral sagittal split osteotomy. Semin Plast Surg. 2013 Aug;27(3):145-8. doi: 10.1055/s-0033-1357111. PMID: 24872760; PMCID: PMC3805998.

  BACKGROUND

• Ahmadvand A, Alavi S, Mehraban SH. An overview of surgery-first orthognathic approach: History, indications and limitations, protocols, and dentoskeletal stability. Dent Res J (Isfahan). 2021 Jun 22;18:47. PMID: 34429867; PMCID: PMC8351934.

  BACKGROUND

• Choi JW, Lee JY. Current concept of the surgery-first orthognathic approach. Arch Plast Surg. 2021 Mar;48(2):199-207. doi: 10.5999/aps.2020.01305. Epub 2021 Mar 15. PMID: 33765739; PMCID: PMC8007470.

  BACKGROUND

• Cariati P, Martínez R, Martínez-Lara I. Psycho-social impact of orthogathic sugery. J Clin Exp Dent. 2016 Dec 1;8(5):e540-e545. doi: 10.4317/jced.53007. PMID: 27957267; PMCID: PMC5149088.

  BACKGROUND

• Khechoyan DY. Orthognathic surgery: general considerations. Semin Plast Surg. 2013 Aug;27(3):133-6. doi: 10.1055/s-0033-1357109. PMID: 24872758; PMCID: PMC3805731.

  BACKGROUND

MeSH Terms

Conditions

Malocclusion; Jaw Abnormalities; Dentofacial Deformities; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral surgeon, PhD student

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 17, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

LI (1)