NCT06392204

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

Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-10-07
• Primary completion: 2025-09-18
• Completion: 2025-09-18
• First posted: 2024-04-30
• Last updated: 2026-04-09

Locations

1 site across 1 country: Egypt