Actively Recruiting

Age: 3Years - 5Years
All Genders
ID06856330

Efficacy of Two Flap Palatoplasty Versus Furlow With Buccinator Flap During Primary Palatoplasty on Speech Development in Children with Cleft Palate

Led by Fayoum University · Updated on 2025-07-28

30

Participants Needed

1

Research Sites

7 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two surgical techniques used during primary palate repair in children with cleft palate, specifically focusing on how these procedures affect speech development. The study involves children aged 3 to 5 years who have previously undergone cleft lip and palate repair by the same craniofacial surgeon. It evaluates speech outcomes by analyzing speech samples recorded in Arabic, assessing aspects like hypernasality, speech clarity, and compensatory speech errors. The study groups consist of about 20 children divided evenly: one group receiving the Furlow palatoplasty combined with a buccal myomucosal flap and the other undergoing two flap palatoplasty. These procedures are observed and their effects on speech are studied without additional intervention. Speech recordings are collected in a soundproof room and analyzed by a specialist in speech disorders. Participants will have their speech recorded through repeated syllables, sentences with high-pressure sounds, and counting from one to ten. These sessions are conducted in a controlled environment to ensure accurate assessment. The primary outcome includes a nasopharyngoscopic examination performed approximately one week after the study begins to observe functional results. The entire participation spans from initial speech recording through completion of this examination.

CONDITIONS

Brief Title

Effect of Furlow Palatoplasty With Buccal Myomucosal Flap on the Speech Development

Who Can Participate

Age: 3Years - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 5 years with previously treated complete cleft lip and palate, nonsyndromic
  • Lip and palate repair performed by one craniofacial surgeon
Not Eligible

You will not qualify if you...

  • Patients with syndromic cleft lip
  • Redo cases
  • Bilateral cleft lip
  • Patients older than 5 years or younger than 3 years
  • Associated cardiac anomalies
  • Any systemic condition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Approximately 1 week

Participants undergo either Furlow palatoplasty with buccal myomucosal flap or two flap palatoplasty performed by a craniofacial surgeon, followed by immediate post-operative care.

1 surgical visit and post-operative assessments

Post-operative Follow-up

Duration - Up to study completion

Participants receive nasopharyngoscopic examinations and monitoring of speech development after surgery.

Approximately weekly visits for about 1 week

Trial Site Locations

Total: 1 location

1

Fayoum University

Al Fayyum, Egypt

Actively Recruiting

Loading map...

Research Team

S

Shaimaa Refahee

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

The Genetics of Neuroendocrine Reproductive Disorders and of...

Kallmann Syndrome

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Speech outcome following primary furlow palatoplasty with buccal myomucosal flap versus two flap palatoplasty in patients with cleft palate.

Shaimaa Mohsen Refahee, Mamdouh Ahmed Aboulhassan, Iman Mohamed Elrouby...

https://pubmed.ncbi.nlm.nih.gov/41420755