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NCT Number: NCT07452315

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and dental medicine

Giza, الجيزة, 12611, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibula free flap

Procedure

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

Primary outcomes

  1. Accuracy of the fibular segments and dental implants

    Time frame: From enrollment "VSP" till the immediate postoperative CT, Throughout the completion of the study, for an average of 1 year

    Accuracy of the fibular segments and dental implants in patients compared to the Virtual Surgical plan, Measured in degrees and millimeters

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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