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Accuracy of Computer Guided Screw Holes Locating Guide and Patient Specific Champy Plate vs Conventional Champy Plate Osteosynthesis in Management of Mandibular Angle Fracture: Randomized Controlled Trial

NCT06838377 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-20

No results posted yet for this study

Summary

the aim of our study is to assess computer guided mandibular fracture reduction and to prove its lower rate of complications and higher accuracy of reduction compared to the conventional approach in management of mandibular angle fracture.

Conditions

  • Mandible Fracture

Interventions

DEVICE

standard Champy mini plate

the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision, Reflect the flap to visualize the broken segments. Full thickness mucoperiosteal flaps were then carefully raised to expose enough underlying alveolar bone then mobilize the broken segment , Arch bar was made to achieve proper occlusion put the Champy 2.0 plate on the ventral surface of the external oblique of the mandible and remove it for further bending using plate pliers for further accommodation of the plate then fix it in place using mono cortical screws.

DEVICE

computer guided screw holes locating guide and Patient Specific Champy plate

the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision, Reflect the flap to visualize the broken segments. Full thickness mucoperiosteal flaps were then carefully raised to expose enough underlying alveolar bone to accommodate the screw holes locating guide and the custom-made Champy plate. , 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 custom-made Champy plate and fix it with screw for passive reduction of the segments. Then suture the mucosa.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06838377 on ClinicalTrials.gov