Assessment of Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial vs High Medial Cut (Randomized Controlled Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Cairo University
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- 3D mandibular condylar position changes
Study Overview
Brief Summary
This study hypotheses that using low medial cut osteotomy BSSO in mandibular setback can be an efficient and effective method to limit the bony segment interferences , decreasing muscles stripping during osteotomy ,decrease condylar torque and so securing preoperative condylar position during BSSO in comparison with using high medial cut BSSO.
Detailed Description
Research question:
Description of research question:
P: Population: Patients with facial skeletal deformity and need for mandibular setback using bilateral sagittal split osteotomy (BSSRO) alone or combined with lefort osteotomy.
I: Intervention: Patients with facial skeletal deformity and need and for mandibular setback using low medial cut osteotomy as modification of bilateral sagittal split ramus osteotomy (BSSRO).
C: Comparator: Patients with facial skeletal deformity and need and for mandibular setback using traditional high medial cut osteotomy bilateral sagittal split ramus osteotomy (BSSRO).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
3D mandibular condylar position changes
Time Frame: Preoperative- 1-month postoperative - 6 months post operative
assessment of condylar position changes in millimetre using C.T.(axial ,coronal and sagital cut. ). 1. Axial condylar head long-axis angle (AHA): angle between the sagittal plane and the axial condylar head axis line 2. Axial condylar head position (AHP): perpendicular distance between the sagittal plane and the most medial point of the condylar head 3. Frontal condylar head long-axis angle (FHA): angle between the axial plane and the frontal condylar head long-axis line 4. Frontal condylar head position (FHP): perpendicular distance between the axial plane and most superior point of the condylar head 5. Sagittal condylar head long-axis angle (SHA): angle between the coronal plane and the sagittal condylar head long-axis line 6. Sagital condylar head position (SHP): perpendicular distance between the coronal plane and the most superior point of the condylar head
Secondary Outcomes
- Assessment of changes in articular disc position(Preoperative , 6month postoperative)
Investigators
Mahmoud Mohammed Mahmoud Hussein Alaswad
Principal Investigator
Cairo University