Specific Screw Holes Locating Surgical Guide and Pre-bent Plates

Not Applicable

• Conditions: Mandibular Fractures
• Interventions: Device: specific screw holes locating surgical guide and pre-bent plates; Device: classical reduction and internal fixation.

• Registration Number: NCT05444829
• Lead Sponsor: Abdallah Gaber Ali Mohamed

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

Study Timeline

• Study First Submitted: 2022-06-22
• Status Verified: 2022-07
• Study Start: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Last Update Submitted: 2022-07-01
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-06
• Primary Completion: 2023-07
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.
  • Patients participating in other studies, if the present protocol could not be properly followed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
specific screw holes locating surgical guide and pre-bent plates	specific screw holes locating surgical guide and pre-bent plates	Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
classical reduction and fixation	classical reduction and internal fixation.	mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.

Primary Outcome Measures

Name	Time	Method
computer tomography	after 3 months	the Computer Tomography Will calculate the segments deviation in mm. after 3 month .