Ireland
--:--IST
Enrolling by invitation Not applicable

How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

NCT05876169 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2022-09-06
Last updated
2023-05-25

Condition(s) studied

Cleft Lip and Palate

Investigational drug(s) / intervention(s)

Orthognathic surgery

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).

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine, Department of Odontology, Umeå University Umeå Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05876169 on ClinicalTrials.gov ↗ ← All trials in Sweden