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

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

Study Overview

• Status: Recruiting
• Conditions: Dentofacial Deformities
• Intervention / Treatment: Procedure: Stability of a two piece PSI deign in splintless maxillary orthognathic surgery; Procedure: Stability of a one piece PSI deign in splintless maxillary orthognathic surgery

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

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shady Shaker, B.D.S.; Phone Number: +201227655079; Email: shadymshakerr@gmail.com
• Study Contact Backup: Name: Adel Aboelfotouh, PhD; Phone Number: +201018871899; Email: a.abouelfetouh@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 12613
      • Recruiting
      • Faculty of Oral and Dental Medicine
      • Contact: Shady Shaker; Email: shadymshakerr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
Active Comparator: 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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability of the new maxillary position	Primary 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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative time	stop watch is used toc calculate the intra-operative time	Intra-operative
Patient satisfaction using Visual Analogue Scale	Patient satisfaction will be gauged using VAS 3 months postoperatively	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 5, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 10, 2022

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Computer guided orthognathic surgery; Splintless orthognathic surgery; Patient specific osteosynthesis; stability of le fort 1 osteotomy
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Dentofacial Deformities
• Other Study ID Numbers: CEBD-CU-2021-10-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Participants agreed to be part of the study but denied sharing any personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No