Maxillary TumorsNCT03757286
Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using FSF With and Without CAD/CAM Customized Cutting Guide
A study testing FSF with CAD\CAM customized cutting guide and FSF without customized cutting guide in people with Maxillary Tumors, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to compare aesthetic results and operation time of Free Scapular flap with and without CAD/CAM customized osteotomy guide for reconstruction of maxillary Defects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillary Tumors
- What is being tested?
- FSF with CAD\CAM customized cutting guide and FSF 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 Maxillary bone.
Who cannot join
- Patients having poor oncological prognosis
- Patients with poor performance status together with other relative or absolute vascular contraindication.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculity of Dentistry-Cairo university
Cairo
Mohammed S Al-wadeai, Phd. student, 00201122538653, alwadai20111@gmail.com
About this study
Official title: Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using Free Scapular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled Clinical Trial)
The aim of the study is to compare aesthetic results and operation time of Free Scapular flap with and without CAD/CAM customized osteotomy guide for reconstruction of maxillary Defects.
Read the detailed description
Maxillofacial defects create unique challenges for the reconstructive surgeon, often involving bony and soft tissue components of the midface. Surgical reconstruction following maxillectomy is currently a topic of interest for reconstructive head and neck surgeons. maxillary defects were reconstructed with maxillofacial prosthetics including obturation. While the latter is an effective reconstruction. Over the past two decades, there has been increasing interest in the use of free tissue transfers of bone to reconstruct the maxilla.
Scapular flap It is an excellent candidate for maxillectomy defects because of its unique feature, which is characterized by additional skin paddles or muscles. and can be harvested along with a part of the scapular bone for bony reconstruction
Traditional reconstructive techniques often lead to suboptimal reconstructions due to inexact planning, poor communication between the resective and reconstructive teams or surgical difficulties in adjusting a free flap and osteosynthesis plates into a three-dimensional (3D) defect without the help of any templates or surgical guides The advent of 3D modeling in head and neck reconstruction has allowed surgeons to improve upon functional and aesthetic outcomes, which are crucial to patient satisfaction and can be difficult to achieve in maxillectomy defects The cutting guides used or not used, however debate still present for its benefits and worth for patient and surgeon. current study to evaluate how such virtual planning with using of customized cutting guide is effective and worth for patient aesthetic and operation time.
our priori-hypothesis is that utilization CAD/CAM assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing maxillary reconstruction using free scapular flap.
In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FSF by CAD/CAM-assisted with customized osteotomy guide to results of another group of patients receive FSF but without customized osteotomy guide. only model will be performed as conventional method aiding in reshaping of reconstruction plate which is another well-established concept of management of maxillary defect.
- Conditions
- Maxillary Tumors
- Being tested
- FSF with CAD\CAM customized cutting guide, FSF without customized cutting guide
- Keywords
- maxillary tumors resection\ reconstruction, CAD\CAM, osteotomy, cutting guide, aesthetic, operation time, free scapular flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSF with CAD\CAM customized cutting guideProcedure or surgery
This began with the acquisition of a high-resolution CT scan of the patient's maxilla and scapula. The CT scan will be sent to the modeling company that produce 3D autoclavable models and cutting guides to be used during resection and scapular harvesting as well as a model of the final reconstructed maxilla.
surgery will performed by two surgical teams one for tumor resection and the other harvesting the flap.
access to the maxilla was obtained and the cutting guides were secured in the planned position; the cuts were completed. The scapular guides were secured to the harvested scapula to replicate the cuts that were planned previously.
The scapula and plate will be fixed and pedicle anastomosis is performed. the operation then completed with soft tissue reconstruction.
FSF without customized cutting guideProcedure or surgery
This began with the acquisition of a high-resolution CT scan of the patient's maxilla .
The C.T scan will be sent to the modeling company for planning three-dimensional model of the maxilla. autoclavable model will be prepared to be used during the workflow for plate reshaping to conforme the prices position of the maxilla.
surgery will performed in a single step by two surgical teams, one for cervicofacial resection and the other for harvesting the flap.
Resection-reconstruction then performed in aconventional surgical manner with microvascular anastomosis. finally the operation will be completed with soft tissue reconstruction as needed.
| Study group | Role | What they receive |
|---|---|---|
| FSF with CAD\CAM customized cutting guide | Experimental | Maxillary reconstruction using free scapular flap with CAD/CAM customized osteotomy guide. Receives: Procedure: FSF with CAD\CAM customized cutting guide |
| FSF without customized cutting guide | Active comparator | maxillary reconstruction using free scapular flap without customized osteotomy guide. CAD/CAM 3D model for maxilla will be used. Receives: Procedure: FSF 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 other side of maxilla.subjectively will be evaluated using VAS.
Measured: at least three months postoperative
Secondary outcomes (1)
operation time
operation time will be recorded intraoperatively in the surgery day as total operation time and ischemic 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 Maxillary 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 Salah Mohammed Al-Wadeai, Cairo University
- Investigators
- Mohammed S Al-wadeai, Phd. student, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757286
- Sponsor's protocol ID
- 654
- 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
Alwadeai MS, Al-Aroomy LA, Shindy MI, Amin AA, Zedan MH. Aesthetic reconstruction of onco-surgical maxillary defects using free scapular flap with and without CAD/CAM customized osteotomy guide. BMC Surg. 2022 Oct 19;22(1):362. doi: 10.1186/s12893-022-01811-9.
PubMed 36261822
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 Maxillary Defects Using Free Scapular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03757286
- Acronym / sponsor ID
- 654
- Conditions
- Maxillary Tumors
- Keywords
- maxillary tumors resection\ reconstruction, CAD\CAM, osteotomy, cutting guide, aesthetic, operation time, free scapular 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 aim of the study is to compare aesthetic results and operation time of Free Scapular flap with and without CAD/CAM customized osteotomy guide for reconstruction of maxillary Defects.
Detailed description
Maxillofacial defects create unique challenges for the reconstructive surgeon, often involving bony and soft tissue components of the midface. Surgical reconstruction following maxillectomy is currently a topic of interest for reconstructive head and neck surgeons. maxillary defects were reconstructed with maxillofacial prosthetics including obturation. While the latter is an effective reconstruction. Over the past two decades, there has been increasing interest in the use of free tissue transfers of bone to reconstruct the maxilla.
Scapular flap It is an excellent candidate for maxillectomy defects because of its unique feature, which is characterized by additional skin paddles or muscles. and can be harvested along with a part of the scapular bone for bony reconstruction
Traditional reconstructive techniques often lead to suboptimal reconstructions due to inexact planning, poor communication between the resective and reconstructive teams or surgical difficulties in adjusting a free flap and osteosynthesis plates into a three-dimensional (3D) defect without the help of any templates or surgical guides The advent of 3D modeling in head and neck reconstruction has allowed surgeons to improve upon functional and aesthetic outcomes, which are crucial to patient satisfaction and can be difficult to achieve in maxillectomy defects The cutting guides used or not used, however debate still present for its benefits and worth for patient and surgeon. current study to evaluate how such virtual planning with using of customized cutting guide is effective and worth for patient aesthetic and operation time.
our priori-hypothesis is that utilization CAD/CAM assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing maxillary reconstruction using free scapular flap.
In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FSF by CAD/CAM-assisted with customized osteotomy guide to results of another group of patients receive FSF but without customized osteotomy guide. only model will be performed as conventional method aiding in reshaping of reconstruction plate which is another well-established concept of management of maxillary defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSF with CAD\CAM customized cutting guide | Experimental | Procedure: FSF with CAD\CAM customized cutting guideMaxillary reconstruction using free scapular flap with CAD/CAM customized osteotomy guide. |
| FSF without customized cutting guide | Active comparator | Procedure: FSF without customized cutting guidemaxillary reconstruction using free scapular flap without customized osteotomy guide. CAD/CAM 3D model for maxilla 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 Maxillary bone.
Key exclusion criteria (2 listed)
- Patients having poor oncological prognosis
- Patients with poor performance status together with other relative or absolute vascular contraindication.
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 |
|---|---|---|
| FSF with CAD\CAM customized cutting guideThis began with the acquisition of a high-resolution CT scan of the patient's maxilla and scapula. The CT scan will be sent to the modeling company that produce 3D autoclavable models and cutting guides to be used during resection and scapular harvesting as well as a model of the final reconstructed maxilla. surgery will performed by two surgical teams one for tumor resection and the other harvesting the flap. access to the maxilla was obtained and the cutting guides were secured in the planned position; the cuts were completed. The scapular guides were secured to the harvested scapula to replicate the cuts that were planned previously. The scapula and plate will be fixed and pedicle anastomosis is performed. the operation then completed with soft tissue reconstruction. | Procedure or surgery | FSF with CAD\CAM customized cutting guide |
| FSF without customized cutting guideThis began with the acquisition of a high-resolution CT scan of the patient's maxilla . The C.T scan will be sent to the modeling company for planning three-dimensional model of the maxilla. autoclavable model will be prepared to be used during the workflow for plate reshaping to conforme the prices position of the maxilla. surgery will performed in a single step by two surgical teams, one for cervicofacial resection and the other for harvesting the flap. Resection-reconstruction then performed in aconventional surgical manner with microvascular anastomosis. finally the operation will be completed with soft tissue reconstruction as needed. | Procedure or surgery | FSF without customized cutting guide |
Primary outcome
Aesthetic
Time frame: at least three months postoperative
aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to other side of maxilla.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 36261822Alwadeai MS, Al-Aroomy LA, Shindy MI, Amin AA, Zedan MH. Aesthetic reconstruction of onco-surgical maxillary defects using free scapular flap with and without CAD/CAM customized osteotomy guide. BMC Surg. 2022 Oct 19;22(1):362. doi: 10.1186/s12893-022-01811-9.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mohammed S Al-wadeai, 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 FSF with CAD\CAM customized cutting guide and FSF without customized cutting guide in people with Maxillary 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 2 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 S Al-wadeai, Phd. student (00201122538653, alwadai20111@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 postoperative). 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 NCT03757286, 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.