Congenital Abnormalities Clinical Trial
Official title:
Digitally Fabricated Inter-occlusal Wafer Versus Wafer-less Distal Segment Repositioning for Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformities (Randomized Controlled Trial)
Research studies continues to attempt testing modifications to refine the treatment protocols through computer assisted design or computer-generated surgical Wafer splints, have greatly revolutionized the incorporation of digital imaging and 3D design in Orthognathic surgery. Integrating computer guided technology in orthognathic surgery aims to to simplify workup and reduce surgical errors, eliminate occlusal discrepancy, increase the realignment accuracy of the distal segments according to the preoperative plan. Implementing a waferless technique raised the question of efficiency versus the use of occlusal wafers and whether it has a significant measurable effect on the surgical outcome and objectives. Rationale for conducting this study is to assess the difference between the effect of computer guided waferless technique and computer guided technique with occlusal wafer on accuracy of postoperative occlusion and condylar position. .
Status | Recruiting |
Enrollment | 24 |
Est. completion date | March 2023 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients in need of bilateral sagittal split osteotomy for mandibular repositioning. - All patients are free from any systemic disease that may affect normal bone healing. - Sufficient dentition to reproduce the occlusal relationships - Patient's consent to participate Exclusion Criteria: - Patients with any systemic disease that may affect normal healing - Intra-bony lesions or infections that may interfere with surgery. - Previous orthognathic surgeries. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mohamed Omara | Cairo | El-Manial |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postop occlusal translational discrepancy (T3): | measured in mm from sagittal, axial, and coronal postop CT images. Measuring error and deviation of postoperative bony segments to the preoperative virtual plan. | Outcomes will be assessed with immediate postoperative CT at T3 (week 3). | |
Primary | Postop occlusal translational discrepancy (T6): | measured in mm from sagittal, axial, and coronal postop CT images. Measuring error and deviation of postoperative bony segments to the preoperative virtual plan. | Outcomes will be assessed with immediate postoperative CT at T4 (week 27). | |
Primary | Postop occlusion rotation and deviation (T3): | measured in degrees from 3D objects preoperative 3D cephalometric landmarks. comparing postoperative occlusal plane rotational deviation in reference to preoperative planned occlusion. | Outcomes will be assessed with immediate postoperative CT at T3 (week 3). | |
Primary | Postop occlusion rotation and deviation (T27): | measured in degrees from 3D objects preoperative 3D cephalometric landmarks. comparing postoperative occlusal plane rotational deviation in reference to preoperative planned occlusion. | Outcomes will be assessed with immediate postoperative CT at T4 (week 27). | |
Primary | 3D spatial deviation error (T3): | Absolute point to point 3D measurements in the 3D virtual environment of the postop 3D bony segments in reference to the preop objects. | Outcomes will be assessed with immediate postoperative CT at T3 (week 3). | |
Primary | 3D spatial deviation error (T27): | Absolute point to point 3D measurements in the 3D virtual environment of the postop 3D bony segments in reference to the preop objects. | Outcomes will be assessed with immediate postoperative CT at T4 (week 27). | |
Secondary | Relapse over time: | The aggregate of the primary outcomes time frame into error and deviation over time to show amount of the repositioned bony segments using the interventional waferless treatment protocol versus the control group using the condylar positioning arms connected to the occlusal wafers. | at week 27, after 6 weeks | |
Secondary | Operative Time | measuring the operative time of the orthognathic surgical procedure, from first incision to closure between the interventional waferless approach and the control group. | immediate postop. |
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