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Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony

Primary Purpose

Dentofacial Deformities

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bimaxillary orthognathic surgery using conventional plates
Bimaxillary orthognathic surgery using patient specific plates
Sponsored by
Hassan Fahmy Hassan Alnimr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentofacial Deformities focused on measuring orthognathic surgery, virtual planning, customized titanium plates, cutting guides, CAD/CAM

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with skeletal class III malocclusion planned for traditional Orthognathic Approach and requiring bimaxillary orthognathic surgeries in which there will be Le Fort I osteotomy with maxillary advancement ranging from 2mm to 5 mm in addition to mandibular setback.
  2. Patients with no signs or symptoms of active TMDs.
  3. Highly motivated patients.

Exclusion Criteria:

  1. Patients who refused to be included in the research.
  2. Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
  3. Patients with intra-bony lesions or infections that may retard the osteotomy healing.

Sites / Locations

  • Faculty of Dentistry, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (Conventional plates)

Group II (Patient specific plates)

Arm Description

Digital intermediate and final interocclusal wafer splints will be designed to guide the maxilla and mandible in the desired position using CAD software (3-matic 11.0; Materialise NV, Leuven, Belgium). The designed splints will be then exported in stereolithography (STL) file format to the additive CAM machine (FORMIGA P 110 printer; EOS e-manufacturing solutions, Munich, Germany) and manufactured in white polyamide (PA2200; EOS e-manufacturing solutions, Munich, Germany) using fused deposition modelling (FDM) technology.The splints will be cold sterilized by overnight immersion in 2% glutaraldehyde. 2.0 conventional mini plates will be used for fixation of maxilla and mandible in the new position.

The cutting guides will be designed on the maxilla and mandible to orient the osteotomy and mark reference holes to be used later for the repositioning/ fixation plate, using CAD software. The designed guide will be then exported in stereolithography (STL) file format to the additive CAM machine and manufactured in white polyamide using fused deposition modelling (FDM) technology. No finishing or polishing was done in order to maintain accuracy. The guides will be cold sterilized by overnight immersion in 2% glutaraldehyde. The patient-specific osteosynthesis plates will be designed to fix the maxilla and mandible in the desired position making use of the previously established reference holes. The designed plates will be exported in STL file format to be manufactured in grade 5 titanium alloy utilizing selective laser sintering (SLS) technology on an additive CAM machine.

Outcomes

Primary Outcome Measures

Skeletal relapse of Le Fort I osteotomy
Skeletal relapse will be assessed through measuring Linear deviations (DT) between the immediate postoperative (T1) and the 12 months postoperative position (T2) in Mimics 19.0 software using hard tissue reference points (A point, Anterior nasal spine, posterior nasal spine, Incisive foramen, Right side Greater palatine foramen, Left side Greater palatine foramen) in relation to three reference planes (Frankfort horizontal plane (FHP), coronal plane, and mid-facial plane (MFP)). Measurements from the reference points to the FHP indicated vertical deviation, to the coronal plane indicated anteroposterior deviation, and to the MFP indicated mediolateral deviation. measurements will be in millimeters.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2022
Last Updated
May 30, 2022
Sponsor
Hassan Fahmy Hassan Alnimr
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1. Study Identification

Unique Protocol Identification Number
NCT05340036
Brief Title
Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony
Official Title
Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony. A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hassan Fahmy Hassan Alnimr

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the Skeletal stability of Le Fort I osteotomy using patient-specific osteosynthesis compared to Mini-plate fixation for patients with skeletal class III malocclusion.
Detailed Description
postsurgical relapse is one of the most common observations that have been reported after fixation of Le Fort I osteotomy cases. Fixation systems with plates and screws are used in oral maxillofacial surgery for the treatment of facial fractures and orthognathic surgery cases. Although they have been used for decades and have become the standard treatment, the materials used in these systems may fail due to excess loading and other causal factors during the surgical procedure, including failure in plate adaptation and fixation to bone, material design, fabrication, and degree of purity of the plate material. In the fixation system, non-customized plates of standard size are used, and are bent to adapt them to the distances required for planning orthognathic surgeries. Therefore, mandatory use of larger plates than those programmed for use in surgeries is required so that they can be bent to enable insertion. Moreover, there are variations in the number of screws required to retain the plates to enable better fixation. The folds of non-customized plates generate stresses that are minimized when using customized plates, because these plates are fabricated individually, with predetermined sizes for each patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentofacial Deformities
Keywords
orthognathic surgery, virtual planning, customized titanium plates, cutting guides, CAD/CAM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Due to the nature of the intervention, therapists cannot be blinded to allocation, but are strongly instructed not to disclose the allocation status to the participant at the follow up assessments. Mrs. Esraa will feed data into the computer in separate datasheets so that the assessors can analyze data without having access to information about the allocation and the procedure.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (Conventional plates)
Arm Type
Active Comparator
Arm Description
Digital intermediate and final interocclusal wafer splints will be designed to guide the maxilla and mandible in the desired position using CAD software (3-matic 11.0; Materialise NV, Leuven, Belgium). The designed splints will be then exported in stereolithography (STL) file format to the additive CAM machine (FORMIGA P 110 printer; EOS e-manufacturing solutions, Munich, Germany) and manufactured in white polyamide (PA2200; EOS e-manufacturing solutions, Munich, Germany) using fused deposition modelling (FDM) technology.The splints will be cold sterilized by overnight immersion in 2% glutaraldehyde. 2.0 conventional mini plates will be used for fixation of maxilla and mandible in the new position.
Arm Title
Group II (Patient specific plates)
Arm Type
Experimental
Arm Description
The cutting guides will be designed on the maxilla and mandible to orient the osteotomy and mark reference holes to be used later for the repositioning/ fixation plate, using CAD software. The designed guide will be then exported in stereolithography (STL) file format to the additive CAM machine and manufactured in white polyamide using fused deposition modelling (FDM) technology. No finishing or polishing was done in order to maintain accuracy. The guides will be cold sterilized by overnight immersion in 2% glutaraldehyde. The patient-specific osteosynthesis plates will be designed to fix the maxilla and mandible in the desired position making use of the previously established reference holes. The designed plates will be exported in STL file format to be manufactured in grade 5 titanium alloy utilizing selective laser sintering (SLS) technology on an additive CAM machine.
Intervention Type
Procedure
Intervention Name(s)
Bimaxillary orthognathic surgery using conventional plates
Intervention Description
le fort I osteotomy will carried out in the classic way guided by the classic landmarks (maxillary roots apices) as described by Wassmund. Complete separation of the maxillary segment using chisels and mallets in regular fashion. Reposition maxilla using the interocclusal wafer while mandible is gently positioned to centric relation position. Mandible is maintained in place until fixation of the maxilla with plates and screws takes place. Complete separation of the mandibular segment using chisels and mallets in regular fashion. Repositioning of mandible using the final interocclusal wafer while condylar segment is gently positioned to centric relation position. Fixation of mandibular segments with plates and/or screws in regular fashion. Incision was closed with 4-0 resorbable sutures in a continuous running fashion.
Intervention Type
Procedure
Intervention Name(s)
Bimaxillary orthognathic surgery using patient specific plates
Intervention Description
The cutting guide of the maxilla will be placed onto the exposed bony surface and manipulated to the best fit. Then, the guide will be fixed using four 2.0-mm screws to avoid any mobilization during drilling of the reference holes. Sixteen reference holes will be established using the cutting guide; eight on each side. Then, a reciprocating saw will be used to perform the planned Le Fort I osteotomy. After adequate maxillary mobilization and removal of bony interferences, the maxilla will be repositioned using the patient-specific osteosynthesis material guided by the previously established reference holes and fixed using 2.0-mm screws. Then, the mandibular cutting guide will be fixed in the same manner and bilateral sagittal split osteotomy will be carried out. After adequate mobilization, the mandible will be repositioned by the patient-specific osteosynthesis material using the reference holes made by cutting guide and fixed using 2.0-mm screws.
Primary Outcome Measure Information:
Title
Skeletal relapse of Le Fort I osteotomy
Description
Skeletal relapse will be assessed through measuring Linear deviations (DT) between the immediate postoperative (T1) and the 12 months postoperative position (T2) in Mimics 19.0 software using hard tissue reference points (A point, Anterior nasal spine, posterior nasal spine, Incisive foramen, Right side Greater palatine foramen, Left side Greater palatine foramen) in relation to three reference planes (Frankfort horizontal plane (FHP), coronal plane, and mid-facial plane (MFP)). Measurements from the reference points to the FHP indicated vertical deviation, to the coronal plane indicated anteroposterior deviation, and to the MFP indicated mediolateral deviation. measurements will be in millimeters.
Time Frame
Linear deviations between immediate postoperative and 12 months postoperative position

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with skeletal class III malocclusion planned for traditional Orthognathic Approach and requiring bimaxillary orthognathic surgeries in which there will be Le Fort I osteotomy with maxillary advancement ranging from 2mm to 5 mm in addition to mandibular setback. Patients with no signs or symptoms of active TMDs. Highly motivated patients. Exclusion Criteria: Patients who refused to be included in the research. Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia. Patients with intra-bony lesions or infections that may retard the osteotomy healing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan Alnimr
Phone
+201002961175
Email
hassan-fahmy@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Alnimr
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
Phone
+20223634965
Email
dentmail@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers.
Citations:
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Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony

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