Custom Inter-Flex 3D plate versus standard titanium plate for fixing mandibular (jaw) fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mataria Teaching Hospital
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: abdelkader hegazy, bachelor
• Email: abdokita35@gmail.com
• Phone: +201119980050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.