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NCT Number: NCT06856330

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

About 20 patient will be collected according to the eligibility criteria and grouped into Group I : 10 patients were treated with furlow with buccinators flap Group II : 10 patients were treated with 2 flap palatoplasty All patients will be examined by an expert Phoniatrician by Recording of speech samples in Arabic language for the children in a soundproof room including repeated syllables, sentences with high-pressure sounds and counting from 1 to 10. The records will be analyzed to assess the degree of hypernasality, speech intelligibility and compensatory speech errors

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

furlow with buccal myomucosal flap

Procedure

patients were treated with furlow with buccal myomucosal flap

two flap palatoplasty

Procedure

patients were treated with two flap palatoplasty

Primary outcomes

  1. nasopharyngoscopic examination

    Time frame: through study completion, an average one week

    this will be done through the nasopharyngoscopic examination of the cleft patients after repair with Furlow with buccinator flap versus two flap palatoplasty. it will assess the grade of velopharyngeal closure during speech

Study contacts

Contact information is provided by the study sponsor or research team.

Shaimaa Refahee

CONTACT

[email protected]

01227407987

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

Efficacy of Two Flap Palatoplasty (TFP) Versus Furlow With Buccinator Flap (FPBF) During Primary Palatoplasty on the Speech Development

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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