Comparing Two Flap Palatoplasty and Furlow with Buccinator Flap for Speech Development in Children with Cleft Palate Aged 3 to 5 Years
Led by Fayoum University · Updated on 2025-07-28
30
Participants Needed
1
Research Sites
7 weeks
Total Duration
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
Research Team
S
Shaimaa Refahee
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Children aged 3 to 5 years with previously treated complete cleft lip and palate, nonsyndromic
Lip and palate repair performed by one craniofacial surgeon
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
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
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
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