Clinical trial Recruiting at 1 site Interventional Ages 18 to 55

Bone plate design for mandible fractures: patient-specific versus conventional plates

Official title: Optimized Osteosynthesis: A Comparative Analysis of Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates (A Randomized Controlled Clinical Trial)

Run by Cairo University · NCT07904897 · Data updated 2026-11-12

This trial tests whether custom, CAD/CAM-made titanium plates help bone density recover better after fixing mandibular body fractures than standard plates.

More Mandibular Fractures trials

Quick facts

Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment26 (estimated)
SponsorCairo University
Academic / other
Locations1 site (Cairo, Giza Governorate)
StatusRecruiting
StartedOctober 12, 2026
Main results expectedNovember 2027
Study endsJanuary 2028
Registry record updatedOctober 29, 2026
Trial IDNCT07904897 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with unilateral or bilateral mandibular body fractures requiring ORIF and without contraindicating health conditions.

Probably not a fit

Patients with comminuted fractures, pre-existing malunions, or conditions prohibiting general anesthesia may not benefit.

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

What this trial studies

This randomized, parallel-group study compares patient-specific titanium plates designed from preoperative CT data with conventional plates that are shaped during surgery for mandibular body fractures. Bone mineral density at the fracture site will be measured by CT-derived Hounsfield Units at baseline and six months after surgery. All procedures follow a standardized surgical protocol performed by a single surgical team under general anesthesia. The primary outcome is the recovery of bone density at the fracture site, aiming to determine if CAD/CAM customization improves osseous healing compared with traditional plating.

Why it matters

Potential benefit: If successful, patients may experience faster or more complete bone healing and stronger fixation with personalized implants.

How similar studies have gone: Prior work in orthopedics has shown promise for patient-specific implants, but evidence for mandibular fractures remains emerging and this study contributes new data.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Unilateral or bilateral mandibular body fracture requiring open reduction and internal fixation (ORIF), presenting either isolated or concurrently with other maxillofacial, midface, or other mandibular fractures.
* Patients in good general health who are medically cleared to undergo major maxillofacial surgery under general anesthesia.

Exclusion Criteria:

* Presence of comminuted fractures or pre-existing malunions at the fracture site.
* Patients with high-risk systemic diseases or any medical conditions that contraindicate the administration of general anesthesia.

Where it's running

  • Faculty of Dentistry- Cairo University
    Cairo, Giza Governorate, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.