Furlow With Buccinator and Velopharyngeal Function

NCT06229587 | Completed DMC

• 1 other identifier: 13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

furlow with buccinator arm

EXPERIMENTAL

Procedure: furlow with buccinator flap

Interventions

furlow with buccinator flap PROCEDURE

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

furlow with buccinator arm

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Hearing Institution

Giza, Egypt

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: February 28, 2024
• Study Completion: March 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

EG (1)