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How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05876169
Enrollment
40
Registered
2023-05-25
Start date
2022-09-06
Completion date
2026-12-12
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

Orthognathic Surgery, Cleft Lip and Palate

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.

Interventions

PROCEDUREOrthognathic 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).

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

s: * Patients accepted for orthognathic surgery due to jaw discrepancies. * Patients given their consent for participation

Exclusion criteria

s: * 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Kinematic outcome variablesPreoperatively, postoperatively 8 weeks, 18 monthsJaw and head movement amplitudes (mm)
Change in Electromyography (EMG)Preoperatively, postoperatively 8 weeks, 18 monthsMuscle activity in micro-Volt in jaw and neck muscles bilaterally
Change in Maximum voluntary occlusal bite force (MVOBF)Preoperatively, postoperatively 8 weeks, 18 monthsNewton (N)
Change in Occlusal contact areaPreoperatively, postoperatively 8 weeks, 18 monthsmm2

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026