Stability of Two Designs of Patient Specific Osteosynthesis For Fixation of LeFort 1 Osteotomy in Orthognathic Surgery
NCT ID: NCT05522348
Last Updated: 2022-09-02
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
34 participants
INTERVENTIONAL
2022-09-05
2022-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Evaluation Between One-piece and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full-arch Prosthesis on Peri-implant Bone Changes.
NCT06790524
Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol
NCT06992557
Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol
NCT06917638
Evaluation of the Effect of Different Thread Designs on Primary Stability of Dental Implant Using Osseodensification Technique in Posterior Maxilla : Randomized Clinical Trial
NCT07242716
Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency
NCT03884699
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Pre-Operative Virtual planning:
After CT examinations, further processing of the DICOM files (Digital Imaging and Communications in Medicine) will be performed using the specialized DICOM image processing software and reconstructed 3D models of the skull will be made. Stone models will be scanned using an optical scanner and stereolithographic files will be imported. Registration of the STL files with the skull model will create a composite model suitable for the construction of necessary devices. These 3D models will be used to design the custom-made cutting guides and fixation devices. The final STL files will be sent to the lab to be milled/printed.
Surgical procedure:
Routine site preparation regarding L.A injections and surgical site disinfections. A maxillary vestibular incision will be made from the maxillary second premolar on one side to the contralateral tooth. The incision will be made 5 mm above the mucogingival junction to leave an adequate cuff for closure. A full thickness mucoperiosteal flap will be reflected to expose the anterior and lateral maxillary walls. Superiorly the reflection exposes the pyriform rim, lateral nasal wall and the infraorbital nerve. Moving backwards, exposure of the zygomatico maxillary buttress is done followed by the maxillary tuberosity and finally the pterygomaxillary junction. The cutting guides will then be placed on the exposed maxilla. The cutting guides will have holes designed in them corresponding to the position of the fixation screws and a slot marking the level of the level of the Le fort 1 osteotomy which will be made using a reciprocating saw. The osteotomy is initiated and the cutting guide is removed.
The nasal septum, both lateral nasal walls and both pterygomaxillary junctions will be osteotomized using a mallet and a chisel and the maxilla finally down fractured and mobilized using Rowe's disimpaction forceps.
Without the use of inter maxillary fixation on an interocclusal wafer. the two-piece PSI will be placed and fixated above the level of the osteotomy using Mini screws. The mobile maxilla is moved until its one and only preplanned position is achieved using the PSI anatomical contours and then the maxilla is fixed. Copious irrigation is done and wound closure using an air cinch and a V-Y closure.
Post-Operative:
Immediate post-operative instructions and medications including analgesics and antibiotics will be given to the patient.
CT scan will be done 4 months post operatively. Then the preoperative and postoperative models will be superimposed to determine the accuracy of the surgically positioned maxilla, comparing it to the virtual plan.
• Control Group
The surgical procedure:
The exact same procedure will be repeated for the control group with the only difference being the fixation device which will consist of a one piece PSI spanning along the entire length of the osteotomy from one zygomaticomaxillary buttress to another.
Post-Operative:
Immediate post-operative instructions and medications including analgesics and antibiotics will be given to the patient.
CT scan will be done 4 months postoperatively.
Strategies to improve adherence to intervention protocols:
Assuring the accuracy of the patient specific fixation by printing skull models of the performed surgery and checking the plates. And such accuracy measures will be photographed and archived.
Criteria for discontinuing allocated interventions for a participant:
* Significant deviation from the virtual plan which will compromise the treatment outcome.
* Hardware failure (Non healing wound dehiscence, screw loosening, plate fracture, etc.)
Relevant concomitant care and interventions that are permitted:
\- The application of postoperative elastics for minor occlusal adjustments. Relevant concomitant care that will be prohibited is the fixation of the separated maxilla in a position other than that dictated by the cutting and drilling guide
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stability of a two piece PSI deign in splintless maxillary orthognathic surgery
A two piece fixation device will be used connecting the nasomaxillary and the zygomaticomaxillary buttresses on both sides
Stability of a two piece PSI deign in splintless maxillary orthognathic surgery
two patient fitted custom made plates will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays
Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
A one piece fixation device will be used extending from one zygomaticomaxillary buttress to the nasomaxillary area then just below the anterior nasal spine then to the same buttresses on the other side
Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
one patient fitted custom made plate will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stability of a two piece PSI deign in splintless maxillary orthognathic surgery
two patient fitted custom made plates will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays
Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
one patient fitted custom made plate will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient seeking definitive surgical correction and refusing orthodontic camouflage.
* Maxillary impaction, advancement and rotations.
* Highly motivated patients.
* Good oral hygiene.
* Patients willing for the surgical procedure and follow-up, with an informed consent
Exclusion Criteria
* Uncooperative patients
* Poor oral hygiene
* Periodontal diseases
* Patients with no desire for surgical correction
* Patients with any diseases that compromise bone or soft tissue healing Patients with local pathology that interfere with the bone healing
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shady Medhat Sabet Shaker
Master's degree candidate
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of oral and dental medicine
Cairo, Manial, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEBD-CU-2021-10-24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.