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Comparaison of the Accuracy of Immediate Fibula Reconstruction With Implants in Fresh Versus Delayed Cases

Accuracy Of Mandibular Reconstruction Using Fibula Free Flaps With Patient Specific Plates And Immediate Dental Implants In Fresh Versus Delayed Cases A Non Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07452315
Enrollment
22
Registered
2026-03-05
Start date
2026-01-02
Completion date
2027-01-02
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandible Reconstruction

Brief summary

The goal of this clinical trial is to learn if mandibular reconstruction with immediate dental implants is as accurate in fresh cases and delayed cases The accuracy of the fibular segments and dental implants will be compared in both groups Participants will: undergo a preoperative CT scan with VSP for mandibular reconstruction Undergo the surgical procedure Undergo an immediate postoperative CT scan and have it superimposed on the virtual plan to detect inaccuracies

Detailed description

The goal of this clinical trial is to learn if mandibular reconstruction with immediate dental implants is as accurate in fresh cases and delayed cases The accuracy of the fibular segments and dental implants will be compared in both groups Participants will: undergo a preoperative CT scan with VSP for mandibular reconstruction Undergo the surgical procedure Undergo an immediate postoperative CT scan and have it superimposed on the virtual plan to detect inaccuracies

Interventions

Immediate reconstruction with the use of PSIs and dental implants in fresh and delayed cases

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

for participants: * Adult patients with conditions requiring mandibular reconstruction using fibula free flaps. * Adult patients diagnosed with neoplastic conditions requiring resection and agreed to immediate reconstruction * Adult patients with segmental mandibular defects resulting from previous pathology, trauma, infectious conditions * Patients willing for the surgical procedure and follow-up, with an informed consent.

Exclusion criteria

for participants: * Patients with significant medical diseases and comorbidities preventing them undergoing lengthy procedures under general anesthesia * Patients with Peripheral Vascular Disease * Patient with known allergy to contrast media in whom a CTA of the lower limbs will not be possible * Patients with Peronea Magna where the peroneal artery is the main blood supply of the lower limbs and its harvesting might result in compromise of the leg vascularity * Patients with no desire for surgical correction * Patients with any diseases that compromise bone or soft tissue healing. Patients with local pathosis that interfere with the bone healing.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the fibular segments and dental implantsFrom enrollment "VSP" till the immediate postoperative CT, Throughout the completion of the study, for an average of 1 yearAccuracy of the fibular segments and dental implants in patients compared to the Virtual Surgical plan, Measured in degrees and millimeters

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026