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Status unknownNCT05626933Updated Nov 25, 2022

Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI

An interventional study of Buccinator myomucosal flap with Furlow palatoplasty in Velopharyngeal Insufficiency, sponsored by Fayoum University. Status unknown at 1 site in Egypt. Open to participants aged 5 Years to 6 Years. Per ClinicalTrials.gov, last updated 2022-11-25.

Sponsored by Fayoum University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
5 Years to 6 Years
Sex
All
01

Study summary

Nasopharyngoscopic examination of the 20 patients with secondary VPI following 2 flap palatoplasty will be done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap and after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty

02

Conditions studied

  • Velopharyngeal Insufficiency
03

In context

Velopharyngeal Insufficiency

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

This study's planned enrollment of 20 is close to the median of 20 across 13 interventional studies indexed under Velopharyngeal Insufficiency.

Browse Velopharyngeal Insufficiency studies →

Lead sponsor

Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.

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

04

Who can participate

Ages eligible
5 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 5-6 years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic.
  • lip and palate repair performed by one craniofacial surgeon

Exclusion criteria

Exclusion Criteria:

  • Patients with syndromic cleft lip.
  • Bilateral cleft lip
  • Patient older younger 5 years.
  • Associated Cardiac anomalies.
  • Any systemic condition
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Buccinator myomucosal flap with Furlow palatoplasty

    Procedure: Buccinator myomucosal flap with Furlow palatoplasty

Interventions

  • ProcedureBuccinator myomucosal flap with Furlow palatoplasty

    Anatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes

06

What researchers measure

Primary outcomes

  1. grade of velopharyngeal closure during speech

    Nasopharyngoscopic examination of the patients with secondary velopharyngeal insufficiency ( VPI) following two flap palatoplasty cleft palate repairs will be done for assessment of velopharyngeal closure grade during speech after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty

    Time frame: immediate postoperative

07

Study locations

1 of 1 sites recruiting
  • Fayoum University
    Fayoum, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05626933
Lead sponsor
Fayoum University
Responsible party
Shaimaa Mohsen (principal investigator, Fayoum University) — Principal investigator
First posted
Nov 25, 2022
Start date
Nov 11, 2022
Primary completion
Dec 30, 2022 (estimated)
Completion
Jan 2, 2023 (estimated)
Last update
Nov 25, 2022

Study contacts

shaimaa refahee, phd
Contact
smr11@fayoum.edu.eg
01227407987
mamdouh aboelhassan, phd
Contact

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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