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Clinical Trials/NCT05522348
NCT05522348UnknownNot Applicable

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

Cairo University1 site in 1 country34 target enrollmentStarted: September 5, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
34
Locations
1
Primary Endpoint
Stability of the new maxillary position

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, 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.

Eligibility Criteria

Sex
All
Accepts 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

Arms & Interventions

Stability of a two piece PSI deign in splintless maxillary orthognathic surgery

Experimental

A two piece fixation device will be used connecting the nasomaxillary and the zygomaticomaxillary buttresses on both sides

Intervention: 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

Active Comparator

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

Intervention: Stability of a one piece PSI deign in splintless maxillary orthognathic surgery (Procedure)

Outcomes

Primary Outcomes

Stability of the new maxillary position

Time Frame: 4 months

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

Secondary Outcomes

  • Intra-operative time(Intra-operative)
  • Patient satisfaction using Visual Analogue Scale(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shady Medhat Sabet Shaker

Master's degree candidate

Cairo University

Study Sites (1)

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