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CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique

NCT06392204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-09

No results posted yet for this study

Summary

This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.

Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.

Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.

Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.

Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.

Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.

Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.

Conditions

  • Mandibular Fractures

Interventions

PROCEDURE

CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate

Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate

PROCEDURE

Champy's techqniue

Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-07
Primary Completion
2025-09-18
Completion
2025-09-18

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 NCT06392204 on ClinicalTrials.gov