Clinical trial Recruiting at 1 site Observational Ages 3 to 5

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.

More Cleft Lip and Palate trials

Quick facts

Study typeObservational
Ages3 Years to 5 Years
SexAll
Enrollment30 (estimated)
SponsorFayoum University
Academic / other
Locations1 site (Al Fayyum)
StatusRecruiting
StartedMarch 25, 2025
Main results expectedJune 1, 2025
Study endsJuly 25, 2025
Registry record updatedJuly 28, 2025
Trial IDNCT06856330 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

  • Fayoum University
    Al Fayyum, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.