An interventional study of mandibular setback using BSSRO in Maxillofacial Abnormalities, Mandible Prognathism and Skeletal Malocclusion, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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).
O: Outcome: Comparing the post-operative condylar positions changes and TMJ functions of two osteotomies.
Research question:
Is using low medial cut osteotomy modification in BSSRO in mandibular setback will provide more control over proximal segment position than traditional high medial cut through:
21 studies on the registry are indexed under Maxillofacial Abnormalities; 2 are open to participants now.
This study's planned enrollment of 24 is below the median of 49 across 10 interventional studies indexed under Maxillofacial Abnormalities.
Browse Maxillofacial Abnormalities studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion criteria:
mandibular setback using low medial cut ostetomy by keeping the cut ''low'' or close to the mandibular occlusal plane and ''short'' or terminating anterior to the lingula.
Other: mandibular setback using BSSRO
mandibular setback by placement of the medial ramus osteotomy cut 'high', just a few millimeters above the lingula, superior and lateral to the entrance point of the inferior alveolar nerve (IAN) into the mandibular foramen ,
Other: mandibular setback using BSSRO
mandibular setback using BSSRO
3D mandibular condylar position changes
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
Time frame: Preoperative- 1-month postoperative - 6 months post operative
Assessment of changes in articular disc position
In order to trace the position of the TMJ disc, a line was drawn from the uppermost point of the articular fossa (UAF, marked as 10) to the lowermost point of the articular tubercle (LAT, marked as 0). This line was continued anteriorly and inferiorly. If the anterior border of the disc was anterior to this line, it was considered negative. These two points were chosen because they did not change with remodelling . Perpendicular lines to this line were drawn in the anterior and posterior borders of the disc. Finally, disc position was determined by averaging anterior (point A) and posterior (point P) disc limits.
Time frame: Preoperative , 6month postoperative
Clinical assessment of maximum incisal opening (MIO)
assessment of changes(in millimetre) in Maximum incisal opening (MIO)
Time frame: Preoperative - 1 months postoperative - 6 months postoperative
pain on TMJ
assessment of changes in severity of pain over TMJ using (pain scale from 0 to 10)
Time frame: Preoperative - 1 months postoperative - 6 months postoperative
sounds on TMJ
assessment of resulted sounds during TMJ function (present or not present)
Time frame: Preoperative - 1 months postoperative - 6 months postoperative
Started Sep 2022 (actual). Primary completion is estimated for Apr 2023, 7 months after the start.
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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