Mandible ReconstructionNCT07452315
Comparaison of the Accuracy of Immediate Fibula Reconstruction With Implants in Fresh Versus Delayed Cases
A study testing fibula free flap in people with Mandible Reconstruction, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandible Reconstruction
- What is being tested?
- fibula free flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2026to 2 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the 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
- Conditions
- Mandible Reconstruction
- Being tested
- fibula free flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibula free flapProcedure or surgery
Immediate reconstruction with the use of PSIs and dental implants in fresh and delayed cases
| Study group | Role | What they receive |
|---|---|---|
| Fresh cases | Active comparator | Cases needing mandibular resection and reconstruction with no prior intervention history Receives: Procedure: fibula free flap |
| Delayed cases | Experimental | Cases needing mandibular reconstruction with history of prior intervention in the form of resection and/or hardware placement Receives: Procedure: fibula free flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the fibular segments and dental implants
Accuracy of the fibular segments and dental implants in patients compared to the Virtual Surgical plan, Measured in degrees and millimeters
Measured: From enrollment "VSP" till the immediate postoperative CT, Throughout the completion of the study, for an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start2 Jan 2026
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible ReconstructionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Medhat Sabet Shaker, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452315
- Sponsor's protocol ID
- PhD1
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07452315
- Acronym / sponsor ID
- PhD1
- Conditions
- Mandible Reconstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh cases | Active comparator | Procedure: fibula free flapCases needing mandibular resection and reconstruction with no prior intervention history |
| Delayed cases | Experimental | Procedure: fibula free flapCases needing mandibular reconstruction with history of prior intervention in the form of resection and/or hardware placement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fibula free flapImmediate reconstruction with the use of PSIs and dental implants in fresh and delayed cases | Procedure or surgery | Delayed cases, Fresh cases |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mandible Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fibula free flap in people with Mandible Reconstruction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.