How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

NCT ID: NCT05876169

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2026-12-12

Brief Summary

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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

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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.

Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prospective longitudinal study design

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

Group Type OTHER

Orthognathic surgery

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine, Department of Odontology, Umeå University

Umeå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2022-kakfunktion

Identifier Type: -

Identifier Source: org_study_id

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