How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Study Overview
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Brief Summary
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In a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (EMG) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical correction will be evaluated. The results will contribute with novel insights on jaw-neck motor function before, in short- and long-term after the surgical process. We will have blinded evaluation of outcomes.

Detailed Description
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Consecutive patients referred to department of Oral and Maxillofacial Surgery, Umeå University Hospital for corrective maxillofacial-mandibular surgery, will offer opportunity to be included in the study. Expected number of patients: 20 - 25 patients annually. Blinded evaluation will be pre-operative and during follow-up 8 weeks and 18 months after surgical correction.

Official Title
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How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Procedure: Orthognathic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criterias: Patients accepted for orthognathic surgery due to jaw discrepancies. Patients given their consent for participation Exclusion Criterias: Patients with syndromes Patients not given their consent for participation Patients unable to follow instructions due to lack of knowledge in Swedish and/or English language

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prospective longitudinal study design<br>Patients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis. | Procedure: Orthognathic surgery<br>* Surgical corrections of the maxilla and/or the mandible. Integrated jaw-neck movement patterns, muscle activity, bite force and occlusal contact area will be registered and mapped with quantitative objective functional variables. The state-of-the-art core equipment to evaluate jaw-neck motor function in detail is located in the Movement Lab (Department of Odontology, Umeå University).<br>* Other names: Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact area;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Kinematic outcome variables | Jaw and head movement amplitudes (mm) | Preoperatively, postoperatively 8 weeks, 18 months | 
| Change in Kinematic outcome variables | Movement cycle time (s) | Preoperatively, postoperatively 8 weeks, 18 months | 
| Change in Kinematic outcome variables | Movement acceleration from start to peak (mm/s2) | Preoperatively, postoperatively 8 weeks, 18 months | 
| Change in Kinematic outcome variables | Jaw movement area (mm2) | Preoperatively, postoperatively 8 weeks, 18 months | 
| Change in Kinematic outcome variables | Jaw movement volume (mm3) | Preoperatively, postoperatively 8 weeks, 18 months | 
| Change in Electromyography (EMG) | Muscle activity in micro-Volt in jaw and neck muscles bilaterally | Preoperatively, postoperatively 8 weeks, 18 months | 
| Change in Maximum voluntary occlusal bite force (MVOBF) | Newton (N) | Preoperatively, postoperatively 8 weeks, 18 months | 
| Change in Occlusal contact area | mm2 | Preoperatively, postoperatively 8 weeks, 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthognathic Surgery, Cleft Lip and Palate