How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

May 16, 2023 updated by: Umeå University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2022

Primary Completion (Estimated)

December 12, 2026

Study Completion (Estimated)

December 12, 2026

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-kakfunktion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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