How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Orthognathic surgery.
- Who it may be relevant to
- Registry conditions: Cleft Lip and Palate. Basic parameters: 16 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Orthognathic surgery
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 measures
- Change in Kinematic outcome variables [Time frame: Preoperatively, postoperatively 8 weeks, 18 months]
- Change in Kinematic outcome variables [Time frame: Preoperatively, postoperatively 8 weeks, 18 months]
- Change in Kinematic outcome variables [Time frame: Preoperatively, postoperatively 8 weeks, 18 months]
- Change in Kinematic outcome variables [Time frame: Preoperatively, postoperatively 8 weeks, 18 months]
- Change in Kinematic outcome variables [Time frame: Preoperatively, postoperatively 8 weeks, 18 months]
- Change in Electromyography (EMG) [Time frame: Preoperatively, postoperatively 8 weeks, 18 months]
- Change in Maximum voluntary occlusal bite force (MVOBF) [Time frame: Preoperatively, postoperatively 8 weeks, 18 months]
- Change in Occlusal contact area [Time frame: Preoperatively, postoperatively 8 weeks, 18 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Faculty of Medicine, Department of Odontology, Umeå University — Umeå
Identifiers
NCT: NCT05876169 · 2022-kakfunktion