Digital Occlusal Wafer Versus Waferless Distal Segment Repositioning for BSSO in Skeletal Mandibular Deformities
NCT05151042 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2021-12-09
Summary
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.
.
Conditions
- Maxillofacial Abnormalities
- Jaw Abnormalities
- Prognathism
- Retrognathia
- Micrognathism
- Dentofacial Deformities
- Congenital Abnormalities
- Craniofacial Abnormalities
Interventions
- PROCEDURE
-
wafer-less approach
Using the software, 3D digitized bony mandible will be virtually osteotomized and repositioned to the new postoperative position. CAD/CAM generated preoperative wafer will be placed on the lower arch dentition, the guide has an extension to guide medial, vertical, oblique cuts as well as screw holes for reference landmarks for proximal segment \& tooth bearing segment. Drilling of all the reference landmarks on the proximal segment and locating medial, vertical, oblique cuts. Removal of guide, then BSSO is performed. The final wafer is placed, the guiding hole on the proximal segment will then be realigned with the previously drilled screw holes, fixation using mono cortical screws then drilling screw holes for plate fixation. Fixation of the osteotomy using 2.0 mm pre-bent mini plates.
- PROCEDURE
-
Computer Guided orthognathic surgery using occlusal wafers
Using the software, 3D digitized bony mandible will be virtually osteotomized and repositioned to the new postoperative position. dental casts will be scanned dental casts are superimposed to the CT cuts into the virtual software environment to produce final wafer CAD/CAM repositioning guide. the generated preoperative wafer will be placed on the lower arch dentition, the guide has an extension to guide medial, vertical, oblique cuts as well as screw holes for reference landmarks for proximal segment \& tooth bearing segment. Drilling of all the reference landmarks on the proximal segment and locating medial, vertical, oblique cuts. Removal of guide, then BSSO is performed. The final wafer is placed, the guiding hole on the proximal segment will then be realigned with the previously drilled screw holes, fixation using mono cortical screws then drilling screw holes for plate fixation. Fixation of the osteotomy using 2.0 mm pre-bent mini plates.
Sponsors & Collaborators
-
Cairo University
lead OTHER
Principal Investigators
-
Mohamed Omara, PhD · Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
-
Hesham O Morsi, MDSc · Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2022-09-30
- Completion
- 2023-03-31
Countries
- Egypt
Study Locations
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