NCT07514091

MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair

MRI Assessment of Velopharyngeal Anatomy in Late Primary Cleft Palate Repair Using Modified Furlow With Buccinator Myomucosal Flap: A Case Series Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The goal of this case series study is to learn if magnetic resonance imaging (MRI) can show how well the palate and throat muscles work at rest and during speech after late cleft palate repair. The surgery uses a technique in which the muscle from the cheek is used to close the gap and repair the cleft and therefore improve speech. The study will answer the question of whether this technique will provide better closure and improved speech in the participants who have not received early treatment. The participants will have the surgery and then have MRI scans 6 months after surgery while resting and speaking specific sounds. Complete speech assessments will also be done 6 months after surgery.

Detailed description

This study will include about 10 children, age 5 years and older, with cleft palate who have not had previous palate surgery. All participants will have surgery using the modified Furlow palatoplasty with a buccinator myomucosal flap. This method is designed to improve muscle function and speech outcomes in children who have late cleft palate repair. Six months after surgery, participants will have MRI scans. The scans will take pictures of the palate and throat muscles while resting and while saying sounds such as "EEE" and "SSS." These images will help researchers see how well the muscles close the gap between the nose and mouth during speech. Participants will also have a speech evaluation six months after surgery. This will include articulation tests and scoring of speech clarity and nasal resonance. The study will take place at Cairo University and New Giza University Hospital. By combining MRI results with speech assessments, researchers aim to show whether MRI is a useful tool for evaluating muscle function after this type of cleft palate repair. The findings may help guide future treatment for children who cannot have early surgery.

Conditions

• Cleft Palate
• Cleft Palate, Unilateral, Complete
• Cleft Lip, Cleft Alveolus and Cleft Palate
• Cleft Palate Repair

Interventions

Type	Name	Description
PROCEDURE	Modified Furlow Palatoplasty combined with buccinator myomucosal flap	The procedure is performed under general anesthesia. After marking a palatal Z-plasty and infiltrating local anesthetic, the parotid duct and buccinator flap donor site are identified. On the left side, a posteriorly based oral myomucosal flap and an anteriorly based nasal flap are created by incising from the uvula to the hard-soft palate junction and laterally toward the hamulus. The levator muscle is fully detached. A small anteriorly based nasal flap is added. On the right side, an anteriorly based oral flap and a posteriorly based nasal myomucosal flap are raised with complete muscle disinsertion. The nasal Z-plasty is interdigitated and sutured, and the oral Z-plasty is closed with minimal muscle overlap. The remaining defect is filled with a right buccal myomucosal flap, which is elevated, tunneled to the palate, inset, and the donor site closed.

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Egypt