Furlow palatoplasty with buccal flap for speech in children with cleft palate
Efficacy of Two Flap Palatoplasty (TFP) Versus Furlow With Buccinator Flap (FPBF) During Primary Palatoplasty on the Speech Development
This project compares two palate repair methods to see if Furlow palatoplasty with a buccal myomucosal flap leads to better speech than two-flap palatoplasty in children aged 3–5 with nonsyndromic cleft palate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | Fayoum University Academic / other |
| Locations | 1 site (Al Fayyum) |
| Trial ID | NCT06856330 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of two surgical techniques for palatal repair, grouping about 20 children into two arms of 10 each: Furlow palatoplasty with a buccal myomucosal flap versus two-flap palatoplasty. All children are aged 3–5 years, nonsyndromic, and had repairs performed by the same craniofacial surgeon. Speech samples are recorded in Arabic in a soundproof room using repeated syllables, sentences with high-pressure sounds, and counting, then analyzed by an expert phoniatrician. Primary outcomes include degree of hypernasality, speech intelligibility, and compensatory speech errors.
Who should consider this trial
Good fit: Ideal candidates are nonsyndromic children aged 3–5 years with previously treated complete cleft lip and palate whose lip and palate repairs were performed by the same craniofacial surgeon.
Not a fit: Children with syndromic clefts, bilateral cleft lip, redo cases, associated cardiac or systemic conditions, or those younger than 3 or older than 5 years are unlikely to be eligible or to benefit from these specific comparisons.
Why it matters
Potential benefit: If successful, the Furlow plus buccal flap approach could improve speech clarity and reduce hypernasality and compensatory errors in young children with cleft palate.
How similar studies have performed: Furlow palatoplasty and buccal myomucosal flap techniques have been reported to improve speech in prior studies, but results are limited and somewhat mixed across the literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 3-5 years old childreen with previous treated complete cleft lip and palate, nonsyndromic. * lip and palate repair performed by one craniofacial surgeon Exclusion Criteria: * Patients with syndromic cleft lip. * Redu cases * Bilateral cleft lip * Patient older 5years or younger 3 years. * Associated Cardiac anomalies. * Any systemic condition
Where this trial is running
Al Fayyum
- Fayoum University — Al Fayyum, Egypt (Recruiting)
Study contacts
- Study coordinator: Shaimaa Refahee
- Email: smr11@fayoum.edu.eg
- Phone: 01227407987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.