Radiographic Assessment of Three Dimensional Mandibular Position Using Splint-less Patient Specific Implant
NCT ID: NCT06160661
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2022-01-01
2024-01-01
Brief Summary
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The cutting guides were first used to predrill screw holes and guide osteotomies.
The custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation
Detailed Description
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The buccal bony surface of the mandible was exposed as a routine sagittal split osteotomy. First, the mandibular cutting guide was installed using the tooth-borne splint portion of the guide.
Second, the lower portion of the guide was temporarily fixed with titanium screws through the designed screw holes on the guide. The planned margins for vertical osteotomy/ ostectomy were then marked by a pencil.
Once the cutting guide was removed, the sagittal split osteotomy was completed as usual. Finally, the distal and proximal segments were fixed together using the custom plates and screw holes that were used by the cutting guide.
Accuracy of preoperative surgical planning, and validation of the use of patient specific implants (PSI) in bilateral sagittal split osteotomy (BSSO) by comparing the planned outcomes to the actual postoperative outcomes by two methos.
A)Evaluation the discrepancy between planned and obtained post-operative position of the mandibular plates, rami, and occlusion by analyzing the discrepancies in terms of rotation (roll, pitch and yaw) and translation (antero-posterior, lateral and vertical). These movements were determined by incorporating the segments in homologous bounding-boxes, aligning the planned model to the post-op result colorimetric map inspection.
B) Measurements of the linear differences between the planned and postoperative positions of the mandibular midlines, the chin, and the gonial angle.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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single arm study
The purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. This approach utilized a personalized orthognathic surgical guide (POSG) system, which comprised a set of cutting guides and 3D printed custom titanium fixation plates for bilateral sagittal split osteotomies (BSSOs).
The cutting guides were first used to predrill screw holes and guide osteotomies. The custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation
mandibular saggital split osteotomy
orthognathic surgery
Interventions
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mandibular saggital split osteotomy
orthognathic surgery
Eligibility Criteria
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Inclusion Criteria
2. Patients should be free from any systemic disease that may affect normal bone healing and predictable outcome.
Exclusion Criteria
2. Intra-bony lesions that may affect the osteotomy healing.
3. Patients with history of radiotherapy on the head and neck region
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Abanoub Fayez Aziz
PhD candidate of oral and maxillofacial surgery , principal investigator
Locations
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Faculty of Dentistry
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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abanoub fayez, PhDcandidate
Role: primary
Other Identifiers
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FDASU-Rec ID032243
Identifier Type: -
Identifier Source: org_study_id