Cancer MaxillaNCT07124988
Results of Different Modalities of Palatomaxillary Reconstruction
A study testing regional flap and distant flap in people with Cancer Maxilla, run by Sohag University at 1 site in Egypt.
Trial summary
Results of different modalities of reconstruction after maxillectomy , prospective comparative study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer Maxilla
- What is being tested?
- regional flap and distant flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jul 2025to 27 Mar 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
- all patients who will undergo maxillectomy (either limited, subtotal or total) due to cancer maxilla ,benign lesions with aggressive behavior ,osteomyelitis, cancer in the surrounding tissues or palatomaxillary trauma.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Results of Different Modalities of Palatomaxillary Reconstruction , Prospective Comparative Study
Results of different modalities of reconstruction after maxillectomy , prospective comparative study
- Conditions
- Cancer Maxilla
- Being tested
- regional flap, distant flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional flapProcedure or surgery
regional flap reconstruction for palatomaxillary defects
distant flapProcedure or surgery
Distant flap reconstruction for palatomaxillary defects
| Study group | Role | What they receive |
|---|---|---|
| regional flap group 1 | Active comparator | Regional flap for palatomaxillary defects as Temporalis muscle Receives: Procedure: regional flap |
| Distant flap group 2 | Active comparator | Distant flap for palatomaxillary defects as Radial forearm free flap Receives: Procedure: distant flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth opening
measures maximal inter incisional distance to :
- normal (more than 35 mm)
- mild restriction (20 to 35mm)
- moderate restriction (10 to 20 mm)
- severe restriction (less than 10 mm)
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start27 Jul 2025
- Primary completion27 Feb 2027 (estimated)
- Study completion27 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer MaxillaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdallah Abozaid, Sohag University
- Investigators
- Mohamed Abdelkader, professor, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124988
- Sponsor's protocol ID
- Soh_Med_25_7_1MD
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Different Modalities of Palatomaxillary Reconstruction , Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07124988
- Acronym / sponsor ID
- Soh_Med_25_7_1MD
- Conditions
- Cancer Maxilla
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 27 Jul 2025 (actual)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 27 Mar 2027 (estimated)
- First posted
- 15 Aug 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.
Results of different modalities of reconstruction after maxillectomy , prospective comparative study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional flap group 1 | Active comparator | Procedure: regional flapRegional flap for palatomaxillary defects as Temporalis muscle |
| Distant flap group 2 | Active comparator | Procedure: distant flapDistant flap for palatomaxillary defects as Radial forearm free flap |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who will undergo maxillectomy (either limited, subtotal or total) due to cancer maxilla ,benign lesions with aggressive behavior ,osteomyelitis, cancer in the surrounding tissues or palatomaxillary trauma.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| regional flapregional flap reconstruction for palatomaxillary defects | Procedure or surgery | regional flap group 1 |
| distant flapDistant flap reconstruction for palatomaxillary defects | Procedure or surgery | Distant flap group 2 |
Primary outcome
Mouth opening
Time frame: 6 months post operative
measures maximal inter incisional distance to : 1. normal (more than 35 mm) 2. mild restriction (20 to 35mm) 3. moderate restriction (10 to 20 mm) 4. severe restriction (less than 10 mm)
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 15 Aug 2025.
- Individual participant dataSharing planned: Yes
Related trials for Cancer Maxilla
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
RecruitingPhase 1
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruiting
3D-Printed Patient-Specific Surgical Plates Versus Conventional Surgical Plates in Jaw Reconstruction
Mandibular Neoplasms, Maxillary Neoplasms
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 Abdelkader, professor study chair
Sohag 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 regional flap and distant flap in people with Cancer Maxilla, run by Sohag 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 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: enrolling by invitation, as of the sponsor's last update on 15 Aug 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?
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?
Mouth opening (time frame: 6 months post operative). 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 15 Aug 2025.