Furlow palatoplasty with buccal flap for speech in children with cleft palate
Official title: Efficacy of Two Flap Palatoplasty (TFP) Versus Furlow With Buccinator Flap (FPBF) During Primary Palatoplasty on the Speech Development
Run by Fayoum University · NCT06856330 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 3 Years to 5 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Fayoum University Academic / other |
| Locations | 1 site (Al Fayyum) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | June 1, 2025 |
| Study ends | July 25, 2025 |
| Registry record updated | July 28, 2025 |
| Trial ID | NCT06856330 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Fayoum University
Al Fayyum, Egypt Recruiting
Study contacts
- Study coordinator: Shaimaa Refahee
- Email: smr11@fayoum.edu.eg
- Phone: 01227407987
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.