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Stability of Two Designs of Patient Specific Osteosynthesis For Fixation of LeFort 1 Osteotomy in Orthognathic Surgery

Stability of Two Different Designs of Patient Specific Osteosynthesis One Piece VS Two Piece For The Fixation of LeFort 1 Osteotomy in Maxillary Orthognathic Surgery A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05522348
Enrollment
34
Registered
2022-08-31
Start date
2022-09-05
Completion date
2022-12-10
Last updated
2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentofacial Deformities

Keywords

Computer guided orthognathic surgery, Splintless orthognathic surgery, Patient specific osteosynthesis, stability of le fort 1 osteotomy

Brief summary

A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of dentofacial deformities

Detailed description

• Intervention Group: - 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

Interventions

PROCEDUREStability 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

PROCEDUREStability 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The participants and the outcome assessor will be blinded to the intervention, however the primary investigator will not be blinded as he performs the surgical procedure.

Intervention model description

randomized clinical trial parallel study and control groups equal randomization positive controlled

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry. * 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

* Medically compromised patients * 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

Design outcomes

Primary

MeasureTime frameDescription
Stability of the new maxillary position4 monthsPrimary outcome will be the positional stability of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 4 months postoperative CT

Secondary

MeasureTime frameDescription
Intra-operative timeIntra-operativestop watch is used toc calculate the intra-operative time
Patient satisfaction using Visual Analogue Scale3 monthsPatient satisfaction will be gauged using VAS 3 months postoperatively

Countries

Egypt

Contacts

Primary ContactShady Shaker, B.D.S.
shadymshakerr@gmail.com+201227655079
Backup ContactAdel Aboelfotouh, PhD
a.abouelfetouh@dentistry.cu.edu.eg+201018871899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026