How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
Primary Purpose
Cleft Lip and Palate
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Orthognathic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate focused on measuring Orthognathic Surgery, Cleft Lip and Palate
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Department of Odontology, Umeå University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Prospective longitudinal study design
Arm Description
Patients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis.
Outcomes
Primary Outcome Measures
Change in Kinematic outcome variables
Jaw and head movement amplitudes (mm)
Change in Kinematic outcome variables
Movement cycle time (s)
Change in Kinematic outcome variables
Movement acceleration from start to peak (mm/s2)
Change in Kinematic outcome variables
Jaw movement area (mm2)
Change in Kinematic outcome variables
Jaw movement volume (mm3)
Change in Electromyography (EMG)
Muscle activity in micro-Volt in jaw and neck muscles bilaterally
Change in Maximum voluntary occlusal bite force (MVOBF)
Newton (N)
Change in Occlusal contact area
mm2
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05876169
Brief Title
How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
Official Title
How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
December 12, 2026 (Anticipated)
Study Completion Date
December 12, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
Orthognathic Surgery, Cleft Lip and Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prospective longitudinal study design
Arm Type
Other
Arm Description
Patients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis.
Intervention Type
Procedure
Intervention Name(s)
Orthognathic surgery
Other Intervention Name(s)
Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact area
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Kinematic outcome variables
Description
Jaw and head movement amplitudes (mm)
Time Frame
Preoperatively, postoperatively 8 weeks, 18 months
Title
Change in Kinematic outcome variables
Description
Movement cycle time (s)
Time Frame
Preoperatively, postoperatively 8 weeks, 18 months
Title
Change in Kinematic outcome variables
Description
Movement acceleration from start to peak (mm/s2)
Time Frame
Preoperatively, postoperatively 8 weeks, 18 months
Title
Change in Kinematic outcome variables
Description
Jaw movement area (mm2)
Time Frame
Preoperatively, postoperatively 8 weeks, 18 months
Title
Change in Kinematic outcome variables
Description
Jaw movement volume (mm3)
Time Frame
Preoperatively, postoperatively 8 weeks, 18 months
Title
Change in Electromyography (EMG)
Description
Muscle activity in micro-Volt in jaw and neck muscles bilaterally
Time Frame
Preoperatively, postoperatively 8 weeks, 18 months
Title
Change in Maximum voluntary occlusal bite force (MVOBF)
Description
Newton (N)
Time Frame
Preoperatively, postoperatively 8 weeks, 18 months
Title
Change in Occlusal contact area
Description
mm2
Time Frame
Preoperatively, postoperatively 8 weeks, 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine, Department of Odontology, Umeå University
City
Umeå
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
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