Comparison of a 3D printed plate method and a standard technique for jaw fracture treatment
Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)
This study is testing if a new 3D printed plate for fixing jaw fractures works better than the usual method to help people heal properly and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06392204 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a computer-designed, patient-specific device and titanium plates manufactured using 3D technology for the treatment of mandibular fractures. Participants will be randomly assigned to either the novel method group or the standard Champy's technique group. Preoperative imaging will be conducted, and surgeries will be performed under general anesthesia, followed by a structured follow-up schedule to monitor recovery and outcomes. The goal is to achieve proper alignment of fractured jaw segments and restore teeth positioning, potentially reducing complications associated with traditional methods.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with unilateral mandibular angle fractures requiring surgical intervention.
Not a fit: Patients with comminuted fractures or systemic diseases affecting healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients with mandibular fractures.
How similar studies have performed: While the use of 3D printing in surgical applications is gaining traction, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Cairo
- Faculty of Dentistry, Cairo University — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.