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Clinical Trials/NCT06856330
NCT06856330RecruitingNot Applicable

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

Fayoum University1 site in 1 country30 target enrollmentStarted: March 25, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
nasopharyngoscopic examination

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
3 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shaimaa Mohsen

associate professor of oral and maxillofacial surgery

Fayoum University

Study Sites (1)

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