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

NCT06392204 | Completed

• 1 other identifier: PSIs
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Fractures

Outcome Measures

Primary Outcomes (1)

• Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.

  Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software

  Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)

Secondary Outcomes (1)

• Postoperative occlusion

  Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)

Study Arms (2)

Custom made reduction guides and 3D grid plates

EXPERIMENTAL

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

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

Stock titanium plates

ACTIVE COMPARATOR

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

Procedure: Champy's techqniue

Interventions

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

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

Custom made reduction guides and 3D grid plates

Champy's techqniue PROCEDURE

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

Stock titanium plates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: October 7, 2023
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: April 9, 2026

Record last verified: 2024-04

Locations

EG (1)