Furlow With Buccinator and Velopharyngeal Function

Cleft Palate Clinical Trial

Official title:

Speech and Middle Ear Outcomes Following Primary Cleft Palate Repair by Furlow Z-plasty Technique With a Buccinator Myomucosal Flap

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06229587
• Other study ID #: 13
• Status: Completed
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done. Middle ear function was assessed by clinical otoscopic examination and by tympanometry to detect the presence or absence of middle ear effusion and the need for tympanostomy tubes. Speech outcomes were assessed using perceptual speech assessment for the degree of hypernasality, compensatory misarticulation and speech intelligibility. Nasopharyngoscopic examination of the patients was done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• - Age 3 to 7 years
• 1ry cleft repair by furrolow with buccal myomucosal flap
• Non syndromic previously treated children
• Cleft repaired by the same surgeon

Exclusion Criteria:

• - Syndromic patient
• Cleft palate repair by any technique except furlow with buccal myomucosal flap

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Procedure:
• furlow with buccinator flap
Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done

Locations

Country	Name	City	State
Egypt	Hearing Institution	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	speech assessement	Nasopharyngoscopic examination of the cleft patients after repair with Furlow with buccinator flap allowing assessment of the grade of velopharyngeal closure during speech	3years