How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Not Applicable

• Conditions: Cleft Lip and Palate

• 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

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