How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Not Applicable

• Conditions: Cleft Lip and Palate
• Interventions: Procedure: Orthognathic surgery

• Registration Number: NCT05876169
• Lead Sponsor: Umeå University

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.

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 Timeline

• Study Start: 2022-09-06
• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-25
• Last Update Posted: 2023-05-25
• Primary Completion: 2026-12-12
• Study Completion: 2026-12-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective longitudinal study design	Orthognathic surgery	Patients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis.

Primary Outcome Measures

Name	Time	Method
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 Kinematic outcome variables	Preoperatively, postoperatively 8 weeks, 18 months	Jaw movement volume (mm3)
Change in Occlusal contact area	Preoperatively, postoperatively 8 weeks, 18 months	mm2

Trial Locations

Locations (1)

Faculty of Medicine, Department of Odontology, Umeå University; 🇸🇪 Umeå, Sweden