An interventional study of Orthognathic surgery in Cleft Lip and Palate, sponsored by Umeå University. Enrolling by invitation at 1 site in Sweden. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Umeå University · Not applicable, Interventional, and Treatment
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.
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Umeå University is the lead sponsor of 272 studies on the registry; 60 are open to participants now.
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Exclusion Criterias:
Patients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis.
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).
Also known as: Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact area
Change in Kinematic outcome variables
Jaw and head movement amplitudes (mm)
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Change in Kinematic outcome variables
Movement cycle time (s)
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Change in Kinematic outcome variables
Movement acceleration from start to peak (mm/s2)
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Change in Kinematic outcome variables
Jaw movement area (mm2)
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Change in Kinematic outcome variables
Jaw movement volume (mm3)
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Change in Electromyography (EMG)
Muscle activity in micro-Volt in jaw and neck muscles bilaterally
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Change in Maximum voluntary occlusal bite force (MVOBF)
Newton (N)
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Change in Occlusal contact area
mm2
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Dec 2026, 51 months after the start.
Of 64 non-industry interventional studies with no phase under Cleft Lip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 33. This study's planned 51 months is above that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 15 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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