Mandible ReconstructionNCT06790628
Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction
A study testing Fibula free flap in people with Mandible Reconstruction, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level). 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
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to Dec 2026
- 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
- Patient who requires mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
- Patient with Mandibular defect >9 cm.
Who cannot join
- Patients with systemic condition counteracting with the surgical procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery contact
Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery contact
Egypt1 site, 1 recruiting
- Recruiting
Oral & Maxillofacial department - Faculty of Dentistry - Cairo University.
Cairo, Cairo Governorate, 11553
About this study
Official title: Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction: a Randomized Controlled Trial.
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
Read the detailed description
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
Design:
A randomized controlled trial with parallel groups and a 1:1 allocation ratio. The study will assess facial symmetry and patient satisfaction over 12 months post-surgery.
Population:
Patients requiring mandibular reconstruction due to conditions like tumors, trauma, or osteomyelitis, with mandibular defects greater than 9 cm.
Interventions:
Group 1: Fibula free flap fixated at the alveolar level (prosthetically favorable position).
Group 2: Fibula free flap fixated at the inferior border level (conventional position).
Setting:
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University.
Duration:
Follow-up over 12 months post-surgery, with key data collection points at baseline, 3 days, 1 week, 1 month, 6 months, and 12 months postoperatively.
- Conditions
- Mandible Reconstruction
- Being tested
- Fibula free flap
- Keywords
- Segmental mandibular defect, mandibular reconstruction, fibula free flap, dental implants, facial symmetry, face scan.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibula free flapProcedure or surgery
surgical technique used in reconstructive surgery where a segment of the fibula bone, along with its blood vessels, is taken from the lower leg and transplanted to reconstruct defects in the mandible due to its length, strength, and ability to support dental implants.
The blood vessels are connected to nearby vessels at the reconstruction site to ensure the bone's survival and integration.
The procedure is highly versatile and often referred to as the "gold standard" for mandibular reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Mandibular reconstruction with fibula free flap fixated in inferior border level. | Active comparator | Fixation of the fibula in the inferior border level (conventional position). Receives: Procedure: Fibula free flap |
| Mandibular reconstruction with fibula free flap fixated in the alveolar level. | Active comparator | Fixation of the fibula in the alveolar level (prosthetically favorable position) leaving 15-17mm till the opposing teeth. Receives: Procedure: Fibula free flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Symmetry
Tool: 3D Stereophotogrammetry face scan. Unit: RMSD: root mean square deviation (Millimeters). Method: superimposition of the face scan color maps on Materialise's Interactive Medical Image Control System (MIMICS) Software.
Measured: 6-12 months
Secondary outcomes (1)
Patient Satisfaction.
Tool: Questionnare (Visual analogue scale) Unit: Scale (1-10)
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Feb 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Sakr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790628
- Sponsor's protocol ID
- OMFS 3-3-60
- Status last verified
- Feb 2025
- First submitted
- 17 Jan 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06790628
- Acronym / sponsor ID
- OMFS 3-3-60
- Conditions
- Mandible Reconstruction
- Keywords
- Segmental mandibular defect, mandibular reconstruction, fibula free flap, dental implants, facial symmetry, face scan.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jan 2025 (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 study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
Detailed description
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
Design:
A randomized controlled trial with parallel groups and a 1:1 allocation ratio. The study will assess facial symmetry and patient satisfaction over 12 months post-surgery.
Population:
Patients requiring mandibular reconstruction due to conditions like tumors, trauma, or osteomyelitis, with mandibular defects greater than 9 cm.
Interventions:
Group 1: Fibula free flap fixated at the alveolar level (prosthetically favorable position).
Group 2: Fibula free flap fixated at the inferior border level (conventional position).
Setting:
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University.
Duration:
Follow-up over 12 months post-surgery, with key data collection points at baseline, 3 days, 1 week, 1 month, 6 months, and 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Mandibular reconstruction with fibula free flap fixated in inferior border level. | Active comparator | Procedure: Fibula free flapFixation of the fibula in the inferior border level (conventional position). |
| Mandibular reconstruction with fibula free flap fixated in the alveolar level. | Active comparator | Procedure: Fibula free flapFixation of the fibula in the alveolar level (prosthetically favorable position) leaving 15-17mm till the opposing teeth. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who requires mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
- Patient with Mandibular defect >9 cm.
Key exclusion criteria (1 listed)
- Patients with systemic condition counteracting with the surgical procedure.
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 flapsurgical technique used in reconstructive surgery where a segment of the fibula bone, along with its blood vessels, is taken from the lower leg and transplanted to reconstruct defects in the mandible due to its length, strength, and ability to support dental implants. The blood vessels are connected to nearby vessels at the reconstruction site to ensure the bone's survival and integration. The procedure is highly versatile and often referred to as the "gold standard" for mandibular reconstruction. | Procedure or surgery | Mandibular reconstruction with fibula free flap fixated in inferior border level., Mandibular reconstruction with fibula free flap fixated in the alveolar level. |
Primary outcome
Facial Symmetry
Time frame: 6-12 months
Tool: 3D Stereophotogrammetry face scan. Unit: RMSD: root mean square deviation (Millimeters). Method: superimposition of the face scan color maps on Materialise's Interactive Medical Image Control System (MIMICS) Software.
1 secondary outcome
Patient Satisfaction.
Time frame: 6-12 months
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 28 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique
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Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
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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.
Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery contact
Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery contact
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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?
Contact Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery (+201097891973, mohamedsakr@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Symmetry (time frame: 6-12 months). 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 28 Feb 2025.