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

Not Applicable

Recruiting

• Conditions: Mandibular Fractures
• Interventions: Procedure: Champy's techqniue; Procedure: CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate

• Registration Number: NCT06392204
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-10-07
• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with unilateral mandibular angle fracture with or without associated mandibular fractures in need of open reduction and internal fixation.
2. Patients above 18 years old
3. Sufficient dentition to reproduce the occlusal relationships
4. Patient's consent to participate

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Exclusion Criteria

1. Patients with comminuted mandibular angle fracture(s)
2. Patients with any systemic disease that may affect normal healing
3. Patients undergoing chemotherapy or radiotherapy related to the head and neck region
4. Intra-bony lesions in the fracture area that may interfere with proper anatomical reduction.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stock titanium plates	Champy's techqniue	Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate
Custom made reduction guides and 3D grid plates	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

Primary Outcome Measures

Name	Time	Method
Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.	Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)	Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software

Secondary Outcome Measures

Name	Time	Method
Postoperative occlusion	Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)	Assessment of postoperative occlusion clinically using a millimeter caliper, occlusion will be categorized into; satisfactory (no gap), mild derangement (gap of 1-2 mm) and deranged (gap more than 2 mm)

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt