Maxillary Sinus NeoplasmsNCT05298969
Temporalis Myofascial Flap Effectiveness
A study testing Temporalis Myofascial flap in people with Maxillary Sinus Neoplasms, run by Assiut University at 1 site in Egypt.
Trial summary
This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Neoplasms
- What is being tested?
- Temporalis Myofascial flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Mar 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with:
- TMJ ankylosis
- Osteomyelitis following mucormycosis
- Following tumor resection like maxillectomy or temporal bone resection
- Following orbital exentration due to tumors or infections
- Following massive trauma
- Facial reanimation
Who cannot join
- • History of head \& neck embolization as it may compromise blood supply of the flap
- Extensive tumors involving maxillary artery
- History of head \& neck radiation or chemotherapy
- Temporalis muscle wasting due to any reason
- Bad general condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Temporalis Myofascial Flap in Reconstruction of Various Cranio-maxillofacial Defects
This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness
- Conditions
- Maxillary Sinus Neoplasms
- Being tested
- Temporalis Myofascial flap
- Keywords
- Temporalis flap, Maxillofacial defects, Reconstruction
- Medical subject headings
- Maxillary Sinus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporalis Myofascial flapProcedure or surgery
Improvement of speech and feeding quality in patients with palatal defects by temporalis myofascial flap
| Study group | Role | What they receive |
|---|---|---|
| Flap survival | Experimental | Harvesting temporalis myofascial flap for cranio-maxillofacial defects Receives: Procedure: Temporalis Myofascial flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of versatility of temporalis myofascial flap in reconstruction of craniomaxillofacial defects in means of flap viability, healing and epithelization
Assessment by regular follow up by pin bricks
Measured: 6 months postoperatively
Secondary outcomes (1)
Assessment of phonation and swallowing efficacy postoperatively
Assessment will be done in regular follow up visits by video fluoroscopy , trials of swallowing and phonation will be assessed by phoniatricians
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Mar 2022
- Primary completionSep 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Model description
- Assessment of temporalis myofascial flap effectiveness in reconstruction of cranio-maxillofacial defects
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Youssef Asham Gendy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298969
- Sponsor's protocol ID
- AssiutU 7
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Temporalis Myofascial Flap in Reconstruction of Various Cranio-maxillofacial Defects
- ClinicalTrials.gov ID
- NCT05298969
- Acronym / sponsor ID
- AssiutU 7
- Conditions
- Maxillary Sinus Neoplasms
- Keywords
- Temporalis flap, Maxillofacial defects, Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Mar 2022 (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.
This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assessment of temporalis myofascial flap effectiveness in reconstruction of cranio-maxillofacial defects
| Arm | Type | Receives |
|---|---|---|
| Flap survival | Experimental | Procedure: Temporalis Myofascial flapHarvesting temporalis myofascial flap for cranio-maxillofacial defects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- patients with:
Key exclusion criteria (5 listed)
- • History of head \& neck embolization as it may compromise blood supply of the flap
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 |
|---|---|---|
| Temporalis Myofascial flapImprovement of speech and feeding quality in patients with palatal defects by temporalis myofascial flap | Procedure or surgery | Flap survival |
Primary outcome
Assessment of versatility of temporalis myofascial flap in reconstruction of craniomaxillofacial defects in means of flap viability, healing and epithelization
Time frame: 6 months postoperatively
Assessment by regular follow up by pin bricks
1 secondary outcome
Assessment of phonation and swallowing efficacy postoperatively
Time frame: 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No
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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.
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 Temporalis Myofascial flap in people with Maxillary Sinus Neoplasms, run by Assiut 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 7 inclusion and 5 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 28 Mar 2022. 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?
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?
Assessment of versatility of temporalis myofascial flap in reconstruction of craniomaxillofacial defects in means of flap viability, healing and epithelization (time frame: 6 months postoperatively). 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 Mar 2022; AzTrials last refreshed its copy on 31 Oct 2026.