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OpenTrials
Completed

NCT Number: NCT07375030

Evaluation of Patient-specific Surgical Stents and Plates for Guided Reduction And Fixation of Mandibular Angle Fractures

This study will evaluate the patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures.

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Key information

Conditions

Mandibular Angle Fracture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

About this study

seven patients with recent mandibular angle fractures indicated for open reduction and internal fixation were treated by patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures. Follow-up extended to 12 weeks. Clinical parameters included pain, operative time, postoperative occlusion, wound healing and mouth opening. Radiographic evaluation was conducted using computed tomography scans acquired preoperatively and postoperatively ,superimposition of the pre and postoperative models will be done to create error map and measure the accuracy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medically fit patients free from relevant conditions contraindicating surgery.
  • Patients with mandibular angle fracture indicated for open reduction and internal fixation.
  • Presented within 2 weeks from trauma.

Exclusion criteria

  • Infected fracture site.
  • Patients with systemic bone diseases.

Treatment and study plan

Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation

Device

Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation

Primary outcomes

  1. Evaluation of accuracy of surgical reduction and fixation

    Time frame: Day 1

    Evaluation of accuracy of surgical guide will be done using slicer and blender, and mimics software with the aid of the preoperative and postoperative CT. Preoperative planning will be merged with the new CT data to identify the accuracy of reduction.

Secondary outcomes

  1. Clinical evaluation for Intra-opreative time

    Time frame: Intra-opreative

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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