Donor SiteNCT07853872
Donor Site Morbidity and Buccinator Muscle Integrity After Buccinator Myomucosal Flap Surgery in Patients With Velopharyngeal Incompetence
An observational study of Donor Site and Morbidity, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate donor site morbidity and buccinator muscle integrity following the use of buccinator myomucosa flap in patients with velopharyngeal incompetence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Donor Site, Morbidity, Buccinator Muscle
- What is being tested?
- Bilateral posteriorly based buccinator myomucosal flap surgery
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2026to 1 Mar 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a prospective comparative and retrospective study designed to evaluate the donor site morbidity and buccinator muscle integrity after buccinator myomucosal flap in patients with velopharyngeal incompetence
Who may be able to join
- Patients diagnosed with velopharyngeal incompetence undergoing palatal lengthening using bilateral posteriorly based buccinator myomucosal flaps.
- Non-syndromic patients.
Who cannot join
- Syndromic cleft patients with associated neuromuscular disorders.
- History of previous cheek surgery affecting the buccinator muscle.
- Patients who declined participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82511
Abdelrahman S Ahmad, MSc, 00201013858729, abdelrahamn.saleh@med.sohag.edu.eg
Mostafa M Mohammad, MD
About this study
Official title: Evaluation of Donor Site Morbidity and Buccinator Muscle Integrity After Buccinator Myomucosal Flap Surgery in Patients With Velopharyngeal Incompetence
The aim of this study is to evaluate donor site morbidity and buccinator muscle integrity following the use of buccinator myomucosa flap in patients with velopharyngeal incompetence.
Read the detailed description
Cleft lip and palate represent one of the most common congenital deformities. The associated disruption of palatal structure leads to abnormal velopharyngeal anatomy, frequently resulting in failure to achieve adequate closure of the velopharyngeal valve even after primary palatal repair.
Buccal artery myomucosal flap Firstly described by Bozola this axial-pattern flap is based on and centered around the buccal artery, a branch of the internal maxillary artery. The flap extends from the maxillary tuberosity to the oral commissure and is primarily used for the closure of mucosal defects involving the posterior hard palate, soft palate, and maxillary alveolus.
- Conditions
- Donor Site, Morbidity, Buccinator Muscle, Integrity, Buccinator Myomucosal Flap Surgery, Velopharyngeal Incompetence
- Being tested
- Bilateral posteriorly based buccinator myomucosal flap surgery
- Medical subject headings
- Velopharyngeal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral posteriorly based buccinator myomucosal flap surgeryProcedure or surgery
Palatal lengthening will be performed using bilateral posteriorly based buccinator myomucosal flaps in patients with velopharyngeal incompetence.
| Study group | Role | What they receive |
|---|---|---|
| Buccinator Myomucosal Flap Group | Patients with velopharyngeal incompetence undergoing palatal lengthening using bilateral posteriorly based buccinator myomucosal flaps. Receives: Procedure: Bilateral posteriorly based buccinator myomucosal flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccinator muscle functional integrity
Buccinator function will be assessed by the 10-second cheek puff test to retain air for 10 seconds. The examiner will record whether the participant completes the test and whether air leakage or facial asymmetry is observed.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start4 Oct 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor SiteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Saleh Ahmad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853872
- Sponsor's protocol ID
- Soh-Med-26-8-22MS
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Donor Site Morbidity and Buccinator Muscle Integrity After Buccinator Myomucosal Flap Surgery in Patients With Velopharyngeal Incompetence
- ClinicalTrials.gov ID
- NCT07853872
- Acronym / sponsor ID
- Soh-Med-26-8-22MS
- Conditions
- Donor Site, Morbidity, Buccinator Muscle, Integrity, Buccinator Myomucosal Flap Surgery, Velopharyngeal Incompetence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 4 Oct 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (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 this study is to evaluate donor site morbidity and buccinator muscle integrity following the use of buccinator myomucosa flap in patients with velopharyngeal incompetence.
Detailed description
Cleft lip and palate represent one of the most common congenital deformities. The associated disruption of palatal structure leads to abnormal velopharyngeal anatomy, frequently resulting in failure to achieve adequate closure of the velopharyngeal valve even after primary palatal repair.
Buccal artery myomucosal flap Firstly described by Bozola this axial-pattern flap is based on and centered around the buccal artery, a branch of the internal maxillary artery. The flap extends from the maxillary tuberosity to the oral commissure and is primarily used for the closure of mucosal defects involving the posterior hard palate, soft palate, and maxillary alveolus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buccinator Myomucosal Flap Group | – | Procedure: Bilateral posteriorly based buccinator myomucosal flap surgeryPatients with velopharyngeal incompetence undergoing palatal lengthening using bilateral posteriorly based buccinator myomucosal flaps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective comparative and retrospective study designed to evaluate the donor site morbidity and buccinator muscle integrity after buccinator myomucosal flap in patients with velopharyngeal incompetence
Key inclusion criteria (2 listed)
- Patients diagnosed with velopharyngeal incompetence undergoing palatal lengthening using bilateral posteriorly based buccinator myomucosal flaps.
- Non-syndromic patients.
Key exclusion criteria (3 listed)
- Syndromic cleft patients with associated neuromuscular disorders.
- History of previous cheek surgery affecting the buccinator muscle.
- Patients who declined participation in the study.
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 |
|---|---|---|
| Bilateral posteriorly based buccinator myomucosal flap surgeryPalatal lengthening will be performed using bilateral posteriorly based buccinator myomucosal flaps in patients with velopharyngeal incompetence. | Procedure or surgery | Buccinator Myomucosal Flap Group |
Primary outcome
Buccinator muscle functional integrity
Time frame: 3 months after surgery
Buccinator function will be assessed by the 10-second cheek puff test to retain air for 10 seconds. The examiner will record whether the participant completes the test and whether air leakage or facial asymmetry is observed.
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Donor Site and Morbidity, 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 2 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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 Abdelrahman S Ahmad, MBBCH (00201013858729, abdelrahamn.saleh@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccinator muscle functional integrity (time frame: 3 months after surgery). 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 6 Oct 2026.