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How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Sponsor
Umeå University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05876169
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
51.2
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Orthognathic surgery
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
Actual Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Dec 12, 2026
Anticipated Study Completion Date :
Dec 12, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Prospective longitudinal study design

Patients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis.

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).
Other Names:
  • Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact area

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Kinematic outcome variables [Preoperatively, postoperatively 8 weeks, 18 months]

      Jaw and head movement amplitudes (mm)

    2. Change in Kinematic outcome variables [Preoperatively, postoperatively 8 weeks, 18 months]

      Movement cycle time (s)

    3. Change in Kinematic outcome variables [Preoperatively, postoperatively 8 weeks, 18 months]

      Movement acceleration from start to peak (mm/s2)

    4. Change in Kinematic outcome variables [Preoperatively, postoperatively 8 weeks, 18 months]

      Jaw movement area (mm2)

    5. Change in Kinematic outcome variables [Preoperatively, postoperatively 8 weeks, 18 months]

      Jaw movement volume (mm3)

    6. Change in Electromyography (EMG) [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) [Preoperatively, postoperatively 8 weeks, 18 months]

      Newton (N)

    8. Change in Occlusal contact area [Preoperatively, postoperatively 8 weeks, 18 months]

      mm2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Department of Odontology, Umeå University Umeå Sweden

    Sponsors and Collaborators

    • Umeå University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Umeå University
    ClinicalTrials.gov Identifier:
    NCT05876169
    Other Study ID Numbers:
    • 2022-kakfunktion
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Umeå University
    Orthognathic Surgery
    Cleft Lip and Palate
    Additional relevant MeSH terms:
    Cleft Lip
    Salicylic Acid

    Study Results

    No Results Posted as of May 25, 2023