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
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
الجيزة
-
Giza, الجيزة, Egypt, 12611
- Faculty of Oral and Dental Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fresh cases
Cases needing mandibular resection and reconstruction with no prior intervention history
|
Immediate reconstruction with the use of PSIs and dental implants in fresh and delayed cases
|
|
Experimental: Delayed cases
Cases needing mandibular reconstruction with history of prior intervention in the form of resection and/or hardware placement
|
Immediate reconstruction with the use of PSIs and dental implants in fresh and delayed cases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrollment "VSP" till the immediate postoperative CT, Throughout the completion of the study, for an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PhD1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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