Mandibular TumorsNCT03757273
Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using FFF With and Without CAD/CAM Customized Cutting Guide
A study testing FFF with CAD/CAM customized cutting guide and FFF without customized cutting guide in people with Mandibular Tumors, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare Aesthetic results and operation time of free fibular flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular defects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Tumors
- What is being tested?
- FFF with CAD/CAM customized cutting guide and FFF without customized cutting guide
- 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
- Jul 2019to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients affected by tumor involving Mandibular bone.
Who cannot join
- Patients having poor oncological prognosis
- Patients with poor performance status together with other relative or absolute vascular contraindication.
- Patients require marginal resection or with bilateral fibular fracture
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry- Cairo University
Cairo
Mohammed E Al-Sabahi, Phd. student, 00201111960834, mea.sabahi2014@gmail.com
About this study
Official title: Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled Clinical Trial)
The purpose of this study is to compare Aesthetic results and operation time of free fibular flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular defects.
Read the detailed description
Oral and maxillofacial tumors posing an important fact as a demanding challenge for surgeons causing face disfigurement which require post-ablation reconstruction. One of the most challenging procedure facing reconstructive surgeons lies in mandibular defects after tumor resection causing facial disharmony affecting aesthetics and function.
Free flaps are considered the gold standard for the reconstruction during oncologic surgery combining a high success rate with low donor site morbidity. Various techniques have been practiced and performed in mandibular defect reconstruction. Hidalgo introduced the fibular graft as an option, offering many Assorted advantages: as it provides a sufficient source for bone and soft tissue harvesting; long reliable vascular pedicle; moreover, only minor donor site morbidity may be involved and flap harvesting require no patient reposition.
Mandibular reconstruction using FFF has become the gold standard. However, flap contouring remain an issue and imprecise with inconvenient or suboptimal final results regrading aesthetic and even more consuming time and efforts owing to poor planning when performed traditionally. Recently, with newly introduced technology and virtual planning, the process has become more uniform and reproducible thus enhancing final outcome improving patient life.
Prefabricated cutting guides may be used may be not, however it still in debate regarding its benefits and worth for patient and surgeon. believing that ability of CAD/CAM technology to achieve Aesthetic and operation time improvement with more detailed evaluation in patients undergoing mandibular reconstruction using free fibular flap with CAD/CAM customized cutting guide.
Our priori-hypothesis is that utilization of CAD/CAM-assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing mandibular reconstruction using free fibular flap. In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FFF by CAD/CAM-assisted with customized osteotomy guide to the results of another group of patients receive FFF but without customized osteotomy guide. only model will be performed as conventional method helping in pre-shaping of reconstruction plate which is another well-established concept of management of mandibular defect.
- Conditions
- Mandibular Tumors
- Being tested
- FFF with CAD/CAM customized cutting guide, FFF without customized cutting guide
- Keywords
- Mandibular tumors resection/reconstruction, CAD/CAM, Osteotomy, Cutting guide, Aesthetic, Operation time, Free fibular flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFF with CAD/CAM customized cutting guideProcedure or surgery
This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton and lower legs. the CT scan will be sent to the modeling company for producing autoclavable 3D models and cutting guides of the mandible and fibula to be used during the workflow as well as a model of the final reconstructed mandible. Surgery will be performed by two surgical teams, one for cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, osteotomy guides secured; cuts then accomplished as planned virtually. fibular flap is harvested and cutting guides secured to replicate osteotomies and reshaping as planned to conform with remaining mandible. fixation and pedicle anastomosis is performed. Finally, the operation completed with soft tissue reconstruction.
FFF without customized cutting guideProcedure or surgery
This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton. the C.T scan will be sent to the modeling company for planning three-dimensional model of the mandible. autoclavable model will be prepared for mandible to be used during the workflow for plate reshaping and positioning to conform with the remaining mandible.
Surgery will be performed by two surgical teams, one in charge of cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, and resection/ reconstruction then performed in conventional surgical manner with microvascular anastomosis. Finally, the operation will be completed with soft tissue reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| FFF with CAD/CAM customized cutting guide | Experimental | Mandibular reconstruction using free fibular flap with CAD/CAM customized osteotomy guide. Receives: Procedure: FFF with CAD/CAM customized cutting guide |
| FFF without customized cutting guide | Active comparator | Mandibular reconstruction using free fibular flap without customized osteotomy guide. CAD/CAM 3D model for mandible will be used. Receives: Procedure: FFF without customized cutting guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic
Aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to the other side of the mandible. subjectively will be evaluated using VAS.
Measured: at least three months post operative
Secondary outcomes (1)
Operation time
Operation time will be recorded intraoperatively in the surgery day as total operation time and ischemia time.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study startJul 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular TumorsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Esmail Abdullah Al-Sabahi, Cairo University
- Investigators
- Mohammed E Al-Sabahi, Phd. student, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757273
- Sponsor's protocol ID
- 653
- Status last verified
- Jul 2019
- First submitted
- 27 Nov 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Sabahi ME, Jamali OM, Shindy MI, Moussa BG, Amin AA, Zedan MH. Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular Flap with and without CAD/CAM Customized Osteotomy Guide: A Randomized Controlled Clinical Trial. BMC Cancer. 2022 Dec 2;22(1):1252. doi: 10.1186/s12885-022-10322-y.
PubMed 36460978
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03757273
- Acronym / sponsor ID
- 653
- Conditions
- Mandibular Tumors
- Keywords
- Mandibular tumors resection/reconstruction, CAD/CAM, Osteotomy, Cutting guide, Aesthetic, Operation time, Free fibular flap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 28 Nov 2018 (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 purpose of this study is to compare Aesthetic results and operation time of free fibular flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular defects.
Detailed description
Oral and maxillofacial tumors posing an important fact as a demanding challenge for surgeons causing face disfigurement which require post-ablation reconstruction. One of the most challenging procedure facing reconstructive surgeons lies in mandibular defects after tumor resection causing facial disharmony affecting aesthetics and function.
Free flaps are considered the gold standard for the reconstruction during oncologic surgery combining a high success rate with low donor site morbidity. Various techniques have been practiced and performed in mandibular defect reconstruction. Hidalgo introduced the fibular graft as an option, offering many Assorted advantages: as it provides a sufficient source for bone and soft tissue harvesting; long reliable vascular pedicle; moreover, only minor donor site morbidity may be involved and flap harvesting require no patient reposition.
Mandibular reconstruction using FFF has become the gold standard. However, flap contouring remain an issue and imprecise with inconvenient or suboptimal final results regrading aesthetic and even more consuming time and efforts owing to poor planning when performed traditionally. Recently, with newly introduced technology and virtual planning, the process has become more uniform and reproducible thus enhancing final outcome improving patient life.
Prefabricated cutting guides may be used may be not, however it still in debate regarding its benefits and worth for patient and surgeon. believing that ability of CAD/CAM technology to achieve Aesthetic and operation time improvement with more detailed evaluation in patients undergoing mandibular reconstruction using free fibular flap with CAD/CAM customized cutting guide.
Our priori-hypothesis is that utilization of CAD/CAM-assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing mandibular reconstruction using free fibular flap. In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FFF by CAD/CAM-assisted with customized osteotomy guide to the results of another group of patients receive FFF but without customized osteotomy guide. only model will be performed as conventional method helping in pre-shaping of reconstruction plate which is another well-established concept of management of mandibular defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFF with CAD/CAM customized cutting guide | Experimental | Procedure: FFF with CAD/CAM customized cutting guideMandibular reconstruction using free fibular flap with CAD/CAM customized osteotomy guide. |
| FFF without customized cutting guide | Active comparator | Procedure: FFF without customized cutting guideMandibular reconstruction using free fibular flap without customized osteotomy guide. CAD/CAM 3D model for mandible will be used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients affected by tumor involving Mandibular bone.
Key exclusion criteria (3 listed)
- Patients having poor oncological prognosis
- Patients with poor performance status together with other relative or absolute vascular contraindication.
- Patients require marginal resection or with bilateral fibular fracture
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 |
|---|---|---|
| FFF with CAD/CAM customized cutting guideThis began with the acquisition of a high-resolution CT scan of the craniofacial skeleton and lower legs. the CT scan will be sent to the modeling company for producing autoclavable 3D models and cutting guides of the mandible and fibula to be used during the workflow as well as a model of the final reconstructed mandible. Surgery will be performed by two surgical teams, one for cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, osteotomy guides secured; cuts then accomplished as planned virtually. fibular flap is harvested and cutting guides secured to replicate osteotomies and reshaping as planned to conform with remaining mandible. fixation and pedicle anastomosis is performed. Finally, the operation completed with soft tissue reconstruction. | Procedure or surgery | FFF with CAD/CAM customized cutting guide |
| FFF without customized cutting guideThis began with the acquisition of a high-resolution CT scan of the craniofacial skeleton. the C.T scan will be sent to the modeling company for planning three-dimensional model of the mandible. autoclavable model will be prepared for mandible to be used during the workflow for plate reshaping and positioning to conform with the remaining mandible. Surgery will be performed by two surgical teams, one in charge of cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, and resection/ reconstruction then performed in conventional surgical manner with microvascular anastomosis. Finally, the operation will be completed with soft tissue reconstruction. | Procedure or surgery | FFF without customized cutting guide |
Primary outcome
Aesthetic
Time frame: at least three months post operative
Aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to the other side of the mandible. subjectively will be evaluated using VAS.
1 secondary outcome
Operation time
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Derived from this study: PubMed 36460978Al-Sabahi ME, Jamali OM, Shindy MI, Moussa BG, Amin AA, Zedan MH. Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular Flap with and without CAD/CAM Customized Osteotomy Guide: A Randomized Controlled Clinical Trial. BMC Cancer. 2022 Dec 2;22(1):1252. doi: 10.1186/s12885-022-10322-y.
- Individual participant dataSharing planned: Undecided
Related trials for Mandibular Tumors
Not yet recruitingPhase 1/2
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma
Recruiting
Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body
Head and Neck Cancer
Recruiting
Mandibular Reconstruction Preplanning (ViPMR)
Oral Cavity Cancer, Oral Cancer
Active, not recruiting
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Impact Molar, Mandible Cyst
Recruiting
AI-based Physiotherapy for Oral Cancer Patients
Oral Cancer
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.
Mohammed E Al-Sabahi, Phd. student principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFF with CAD/CAM customized cutting guide and FFF without customized cutting guide in people with Mandibular Tumors, 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed E Al-Sabahi, Phd. student (00201111960834, mea.sabahi2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aesthetic (time frame: at least three months post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757273, which also lists 1 linked publication.
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 24 Jul 2019.