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Clinical Trials/NCT05444829
NCT05444829
Unknown
Not Applicable

Precision of Patient Specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Work-flow in Management of Class III Mandibular Fractures

Abdallah Gaber Ali Mohamed0 sites26 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mandibular Fractures
Sponsor
Abdallah Gaber Ali Mohamed
Enrollment
26
Primary Endpoint
computer tomography
Last Updated
3 years ago

Overview

Brief Summary

The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow

Detailed Description

Research question: Does the use of screw holes locating surgical guide \& pre-bent plates osteosynthesis accurately reduce class III mandibular fractures regarding segments integrity and occlusion more than the classical reduction and fixation? Statement of the problem: Mandibular fractures are the most frequently occurring fractures within the maxillofacial injuries. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current ,standard approach of mandibular fracture reduction and fixation includes : (improper alignment of segments ,malocclusion ,nerve affections and related teeth roots injury). There is a possibility to overcome these limitations with the help of computer-guided surgery . The introduction of CAD/CAM software has provided surgeons with an opportunity to perform virtual manipulations of CT datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication . The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the conventional work flow Rationale for conducting the research: Through computer guided mandibular fracture reduction investigators can provide proper segment alignment with subsequent accurate post-operative occlusion in addition reduce intra-operative time , post-operative pain and edema

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
September 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Abdallah Gaber Ali Mohamed
Responsible Party
Sponsor Investigator
Principal Investigator

Abdallah Gaber Ali Mohamed

Researcher

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation.
  • Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
  • Both genders males and females will be included.

Exclusion Criteria

  • • General contraindications to surgery.
  • Patients with fresh fractures (mobile segments).
  • Patients with unfavourable nor comminuted fractures.
  • Subjected to irradiation in the head and neck area less than 1 year before fixation.
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.

Outcomes

Primary Outcomes

computer tomography

Time Frame: after 3 months

the Computer Tomography Will calculate the segments deviation in mm. after 3 month .

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