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RecruitingNCT07853872Updated Oct 6, 2026

Donor Site Morbidity and Buccinator Muscle Integrity After Buccinator Myomucosal Flap Surgery in Patients With Velopharyngeal Incompetence

An observational study in Donor Site, Morbidity and Buccinator Muscle, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Sohag University · Observational

Updated Oct 6, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Donor Site
  • Morbidity
  • Buccinator Muscle
  • Integrity
  • Buccinator Myomucosal Flap Surgery
  • Velopharyngeal Incompetence
03

In context

Velopharyngeal Insufficiency

22 studies on the registry are indexed under Velopharyngeal Insufficiency; 10 are open to participants now.

Browse Velopharyngeal Insufficiency studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • Patients diagnosed with velopharyngeal incompetence undergoing palatal lengthening using bilateral posteriorly based buccinator myomucosal flaps.
  • Non-syndromic patients.

Exclusion criteria

Exclusion Criteria:

  • Syndromic cleft patients with associated neuromuscular disorders.
  • History of previous cheek surgery affecting the buccinator muscle.
  • Patients who declined participation in the study.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • Buccinator Myomucosal Flap Group

    Patients with velopharyngeal incompetence undergoing palatal lengthening using bilateral posteriorly based buccinator myomucosal flaps.

    Procedure: Bilateral posteriorly based buccinator myomucosal flap surgery

Interventions

  • ProcedureBilateral posteriorly based buccinator myomucosal flap surgery

    Palatal lengthening will be performed using bilateral posteriorly based buccinator myomucosal flaps in patients with velopharyngeal incompetence.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Sohag University
    Sohag, 82511, Egypt
    • Abdelrahman S Ahmad, MSc · Contact · abdelrahamn.saleh@med.sohag.edu.eg · 00201013858729
    • Mostafa M Mohammad, MD · Sub investigator
    • Ahmed S Mazeed, MD · Sub investigator
    • Ahmad M Abd-elmoniem, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 6, 2026
Sites
Sohag University is now Recruiting
Oct 6, 2026
Start date
Oct 1, 2026→Oct 4, 2026 (actual)
Oct 6, 2026
Registered
First appeared on the registry
Oct 2, 2026
Show all 2 updates
  1. Oct 6, 2026
    Not yet recruiting→Recruiting
    Sohag University is now Recruiting
    Start date Oct 1, 2026→Oct 4, 2026 (now actual)
    + 1 other change: verification date
  2. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07853872
Lead sponsor
Sohag University
Responsible party
Abdelrahman Saleh Ahmad (Resident of Plastic Surgery, Faculty of Medicine, Sohag University, Egypt, Sohag University) — Principal investigator
First posted
Oct 2, 2026
Start date
Oct 4, 2026
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Oct 6, 2026

Study contacts

Abdelrahman S Ahmad, MBBCH
Contact
abdelrahamn.saleh@med.sohag.edu.eg
00201013858729

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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