Using virtual planning to guide jaw tumor removal and reconstruction with bone from the hip
Does Computer-assist Virtual Lesion Segmentation Ushers to a Change in the Literature Consensus Regarding Mandibular Ameloblastoma Radiographic Safety Margin?. A Clinical Case Series
This project tries CT-guided virtual surgical planning to help surgeons get clear margins and rebuild the jaw in people with segmental mandibular ameloblastoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Trial ID | NCT07306962 on ClinicalTrials.gov |
What this trial studies
This single-center interventional protocol will enroll 10 patients with biopsy-confirmed ameloblastoma requiring segmental mandibular resection that spares the condyle and will use preoperative CT-based virtual surgical planning (VSP) to create resection and reconstruction guides. All defects will be reconstructed using bicortical anterior iliac crest bone blocks planned in a 1:1 cortical-to-cancellous ratio and positioned with the VSP guides. Resected specimens will undergo three-dimensional radiographic analysis to measure how closely the surgical result matches the VSP and histopathological analysis to confirm margin status. Outcomes will emphasize VSP accuracy, radiographic safety margins, and early indicators of recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed ameloblastoma who require a segmental mandibular resection not involving the condyle and who have no active infection or prior resection of the lesion.
Not a fit: Patients with condylar involvement, active infection at the resection site, or recurrent lesions after prior surgery are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could improve surgical accuracy, increase the likelihood of complete tumor removal, and make jaw reconstructions more predictable.
How similar studies have performed: CT-guided VSP has improved surgical accuracy in other mandibular reconstruction series, though using anterior iliac crest bicortical blocks for segmental defects with concurrent histopathological margin confirmation is less commonly reported.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with histologically confirmed ameloblastoma using a preoperative biopsy. 2. Patients with ameloblastoma that require segmental mandibular continuity defect, not involving the condyle. Exclusion Criteria 1. Patients with lateral segmental mandibular defect involving the condyle. 2. Patients with an active infection at the site of resection. 3. Patients with recurrent lesion after resection.
Where this trial is running
Alexandria, Alexandria Governorate
- Faculty of Dentistry, Alexandria University — Alexandria, Alexandria Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: yehia A El-Mahallawy, PhD — Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
- Study coordinator: yehia A El-Mahallawy., PhD
- Email: yehia.el-mahallawy@alexu.edu.eg
- Phone: +201007217014.
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.