How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Cleft Lip and Palate Clinical Trial

Official title:

How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05876169
• Other study ID #: 2022-kakfunktion
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: December 12, 2026

Study information

• Verified date: May 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 12, 2026
• Est. primary completion date: December 12, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

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).

Locations

Country	Name	City	State
Sweden	Faculty of Medicine, Department of Odontology, Umeå University	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

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