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

NCT06856330 | Recruiting DMC

• 1 other identifier: 55
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (1)

• nasopharyngoscopic examination

  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

  through study completion, an average one week

Study Arms (2)

two flap palatoplasty group

Procedure: two flap palatoplasty

furlow with buccal myomucosal flap group

Procedure: furlow with buccal myomucosal flap

Interventions

furlow with buccal myomucosal flap PROCEDURE

patients were treated with furlow with buccal myomucosal flap

furlow with buccal myomucosal flap group

two flap palatoplasty PROCEDURE

patients were treated with two flap palatoplasty

two flap palatoplasty group

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

3-5 year old children with treated cleft palate

You may qualify if:

• years old childreen with previous treated complete cleft lip and palate, nonsyndromic.
• lip and palate repair performed by one craniofacial surgeon

You may not qualify if:

• Patients with syndromic cleft lip.
• Redu cases
• Bilateral cleft lip
• Patient older 5years or younger 3 years.
• Associated Cardiac anomalies.
• Any systemic condition

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

RECRUITING

Related Publications (1)

• Refahee SM, Aboulhassan MA, Elrouby IM, Abd-El-Ghafour M. Speech outcome following primary furlow palatoplasty with buccal myomucosal flap versus two flap palatoplasty in patients with cleft palate. Clin Oral Investig. 2025 Dec 20;30(1):19. doi: 10.1007/s00784-025-06695-6.

  PMID: 41420755 DERIVED

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shaimaa Refahee

CONTACT

01227407987; smr11@fayoum.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of oral and maxillofacial surgery

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 4, 2025
• Study Start: March 25, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 25, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

EG (1)