NCT05876169

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Sep 2022Dec 2026

Study Start

First participant enrolled

September 6, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2026

Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

May 2, 2023

Last Update Submit

May 16, 2023

Conditions

Cleft Lip and Palate

Keywords

Orthognathic SurgeryCleft Lip and Palate

Outcome Measures

Primary Outcomes (8)

  • Change in Kinematic outcome variables

    Jaw and head movement amplitudes (mm)

    Preoperatively, postoperatively 8 weeks, 18 months

  • Change in Kinematic outcome variables

    Movement cycle time (s)

    Preoperatively, postoperatively 8 weeks, 18 months

  • Change in Kinematic outcome variables

    Movement acceleration from start to peak (mm/s2)

    Preoperatively, postoperatively 8 weeks, 18 months

  • Change in Kinematic outcome variables

    Jaw movement area (mm2)

    Preoperatively, postoperatively 8 weeks, 18 months

  • Change in Kinematic outcome variables

    Jaw movement volume (mm3)

    Preoperatively, postoperatively 8 weeks, 18 months

  • Change in Electromyography (EMG)

    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)

    Newton (N)

    Preoperatively, postoperatively 8 weeks, 18 months

  • Change in Occlusal contact area

    mm2

    Preoperatively, postoperatively 8 weeks, 18 months

Study Arms (1)

Prospective longitudinal study design

OTHER

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

Procedure: Orthognathic surgery

Interventions

Orthognathic surgeryPROCEDURE

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).

Also known as: Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact area
Prospective longitudinal study design

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Department of Odontology, Umeå University

Umeå, Sweden

Location

MeSH Terms

Conditions

Cleft Lip

Interventions

Orthognathic SurgeryHead MovementsBite Force

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgery, OralDentistryMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDental Occlusion

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 25, 2023

Study Start

September 6, 2022

Primary Completion (Estimated)

December 12, 2026

Study Completion (Estimated)

December 12, 2026

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)