Status:

NOT_YET_RECRUITING

Patient-Specific Guides vs. Classical Workflow in Class IV Mandibular Fracture Fixation

Lead Sponsor:

Mohamed abdelsalam Gaber elkhouly

Conditions:

Mandibular Class Iv Fractures

Eligibility:

All Genders

Phase:

NA

Brief Summary

This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and rel...

Eligibility Criteria

Inclusion

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

Exclusion

  • General contraindications to surgery.
  • Patients with unfavorable or comminuted fractures.
  • Subjected to irradiation in the head and neck area less than 1 year before fixation.
  • 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.

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2027

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT07153354

Start Date

October 1 2025

End Date

October 1 2027

Last Update

September 3 2025

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