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

Primary Purpose

Dentofacial Deformities

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Stability of a two piece PSI deign in splintless maxillary orthognathic surgery
Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentofacial Deformities focused on measuring Computer guided orthognathic surgery, Splintless orthognathic surgery, Patient specific osteosynthesis, stability of le fort 1 osteotomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of oral and dental medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2022
Last Updated
September 1, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05522348
Brief Title
Stability of Two Designs of Patient Specific Osteosynthesis For Fixation of LeFort 1 Osteotomy in Orthognathic Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentofacial Deformities
Keywords
Computer guided orthognathic surgery, Splintless orthognathic surgery, Patient specific osteosynthesis, stability of le fort 1 osteotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial parallel study and control groups equal randomization positive controlled
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stability of a two piece PSI deign in splintless maxillary orthognathic surgery
Arm Type
Experimental
Arm Description
A two piece fixation device will be used connecting the nasomaxillary and the zygomaticomaxillary buttresses on both sides
Arm Title
Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Stability of a two piece PSI deign in splintless maxillary orthognathic surgery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Stability of the new maxillary position
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Intra-operative time
Description
stop watch is used toc calculate the intra-operative time
Time Frame
Intra-operative
Title
Patient satisfaction using Visual Analogue Scale
Description
Patient satisfaction will be gauged using VAS 3 months postoperatively
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shady Shaker, B.D.S.
Phone
+201227655079
Email
shadymshakerr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adel Aboelfotouh, PhD
Phone
+201018871899
Email
a.abouelfetouh@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of oral and dental medicine
City
Cairo
State/Province
Manial
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shady Shaker
Email
shadymshakerr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participants agreed to be part of the study but denied sharing any personal data

Learn more about this trial

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

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