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Enrolling by Invitation

NCT Number: NCT05876169

How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Department of Odontology, Umeå University

Umeå, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthognathic Surgery

Procedure

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).

Other names: Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact area

Primary outcomes

  1. Change in Kinematic outcome variables

    Time frame: Preoperatively, postoperatively 8 weeks, 18 months

    Jaw and head movement amplitudes (mm)

  2. Change in Kinematic outcome variables

    Time frame: Preoperatively, postoperatively 8 weeks, 18 months

    Movement cycle time (s)

  3. Change in Kinematic outcome variables

    Time frame: Preoperatively, postoperatively 8 weeks, 18 months

    Movement acceleration from start to peak (mm/s2)

  4. Change in Kinematic outcome variables

    Time frame: Preoperatively, postoperatively 8 weeks, 18 months

    Jaw movement area (mm2)

  5. Change in Kinematic outcome variables

    Time frame: Preoperatively, postoperatively 8 weeks, 18 months

    Jaw movement volume (mm3)

  6. Change in Electromyography (EMG)

    Time frame: Preoperatively, postoperatively 8 weeks, 18 months

    Muscle activity in micro-Volt in jaw and neck muscles bilaterally

  7. Change in Maximum voluntary occlusal bite force (MVOBF)

    Time frame: Preoperatively, postoperatively 8 weeks, 18 months

    Newton (N)

  8. Change in Occlusal contact area

    Time frame: Preoperatively, postoperatively 8 weeks, 18 months

    mm2

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 25, 2023
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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