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

July 24, 2025 updated by: Shaimaa Mohsen, Fayoum University

Efficacy of Two Flap Palatoplasty (TFP) Versus Furlow With Buccinator Flap (FPBF) During Primary Palatoplasty 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Recruiting
        • Fayoum University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

3-5 year old children with treated cleft palate

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
two flap palatoplasty group
Procedure: two flap palatoplasty
patients were treated with two flap palatoplasty
furlow with buccal myomucosal flap group
Procedure: furlow with buccal myomucosal flap
patients were treated with furlow with buccal myomucosal flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Actual)

June 1, 2025

Study Completion (Estimated)

July 25, 2025

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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