Custom Inter-Flex 3D plate versus standard titanium plate for fixing mandibular (jaw) fractures
Evaluation of the Efficacy of Custom-Made Inter-flex Three-Dimensional Plate in Treatment of Mandibular Fracture A Randomized Controlled Clinical Trial
This trial will test whether a custom Inter-Flex 3D plate works better than ready-made titanium plates to repair recent, uninfected jaw fractures in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Suez Canal University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07263893 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial will treat 20 mandibular fracture sites divided equally into two groups: one fixed with a custom-made Inter-Flex three-dimensional plate and the other with ready-made titanium plates. Surgical planning for the custom plates uses digital modeling to produce a patient-specific fit, and outcomes include operative time, postoperative infection, occlusion, stability of the mandibular border, mouth opening, and radiographic healing. Follow-up visits occur immediately after surgery and at approximately 3 and 6 months to document clinical and radiographic outcomes. The trial is conducted at Mataria Teaching Hospital under Suez Canal University with standard open reduction and internal fixation techniques for all participants.
Who should consider this trial
Good fit: Adults with recent, uninfected, minimally displaced mandibular fractures that require open reduction and internal fixation and who are medically fit (ASA-1) are ideal candidates.
Not a fit: Patients with comminuted or infected fractures, osteoporosis, completely edentulous jaws, young children, or significant medical comorbidities are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, custom Inter-Flex 3D plates could shorten operative time and improve anatomical and functional restoration, potentially reducing mal-union and infection risk.
How similar studies have performed: Previous small series and biomechanical studies of patient-specific and 3D-designed mandibular plates have shown promising fit and functional results, but randomized evidence directly comparing them to standard plates is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable mandibular fractures 2. Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate,3 months,6 months. 3. A fracture that demands open reduction and internal fixation 4. Patients under ASA-1 category Exclusion Criteria: 1. Comminuted, infected mandibular fracture. 2. Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth. 3. Patient with osteoporosis 4. Medical compromised patient (Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), Recent (\<3 months) MI, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, shock, sepsis, undergoing regularly scheduled dialysis, history (\>3 months) 5. Fractures in completely edentulous patients
Where this trial is running
Cairo
- Mataria Teaching Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: abdelkader hegazy, bachelor
- Email: abdokita35@gmail.com
- Phone: +201119980050
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.