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

April 5, 2026 updated by: Dina Adel, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

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
      • Cairo, Egypt
        • Cairo university

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Non-syndromic cleft palate (La Veau I-IV)
  • No prior palatal surgery
  • Consent for MRI and follow-up

Exclusion Criteria:

  • Syndromic clefts or associated craniofacial anomalies.
  • Systemic co-morbidities
  • Previous palatal surgery.
  • Contraindications to MRI.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cleft palate group
Patients undergoing late primary cleft palate repair with Modified Furlow Palatoplasty combined with buccinator myomucosal flap
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Velopharyngeal assessment
Time Frame: 6 Months
The points measured to assess velopharyngeal anatomy are: Velar Length Pharyngeal Depth, Effective Velar length, Velar thickness, VP Gap. All measurements will be in mm. 3D T2-weighted sequence is used to capture high-resolution anatomical details at rest. Rapid 2D sequences assess velopharyngeal closure during sustained phonation. Sagittal and oblique coronal views will be captured. The sagittal plane provides an overall view of velopharyngeal structures, while the oblique coronal plane is specifically designed to visualize the LVP and assess closure pattern. Measurements on the MRI will be taken by primary and secondary raters to examine the intra- and inter-observer reliability. All patients will have their MRI taken with the same machine with uniform MRI acquisition parameters
6 Months
VP ratio
Time Frame: 6 months
this is a ratio calculated by dividing Velar length/Pharyngeal depth.
6 months
EVP ratio
Time Frame: 6 months
This is a ratio calculated by dividing Effective Velar length/Pharyngeal depth
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech intelligibility
Time Frame: 6 months after surgery
By Standardized articulation tests, speech intelligibility will be scored according to speech intelligibility scale, ranged from 0 to 3 (0 = within normal limits, 1 = mild speech intelligibility, 2 = moderate speech intelligibility, 3 = severe speech
6 months after surgery
Hypernasality
Time Frame: 6 months after surgery
By Perceptual speech evaluation which will be done by the same speech pathologist for all patients. Perceptual speech assessment will be performed by recording the repeated different syllables, sentences and counting from 1 to 10 by the patients in a soundproof room. All the used sentences will be in Arabic language. The records will be assessed by the phoniatrician to detect the speech disorders as the severity of nasal resonance. the severity of nasal resonance will be scored according to the hypernasality scale ranged from 0 to 3 (0 = no hyper nasality, 1 = mild hypernasality, 2 = moderate hypernasality, 3 = severe hypernasality)
6 months after surgery
Nasal emission
Time Frame: 6 months after surgery
By Perceptual speech evaluation and will be evaluated qualitatively as absent or present.
6 months after surgery

Collaborators and Investigators

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

Sponsor

Cairo University

Collaborators

NewGiza University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI-VPI-FURL-BMF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study will share individual participant data that underlie the primary and secondary outcomes reported in the final publication. This includes de-identified demographic data, baseline characteristics, surgical details, and outcome measures collected throughout the study period. Only data necessary to reproduce the analyses and results will be shared, with all direct identifiers removed to protect participant confidentiality.

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Access Criteria

De-identified MRI data, surgical details relevant to the modified Furlow with buccinator myomucosal flap technique, and supporting documentation may be shared with qualified researchers. Data will be provided for ethically approved analyses that align with the study objectives, such as investigations of velopharyngeal anatomy or cleft palate repair outcomes. Requests will be reviewed by the principal investigator to ensure scientific merit, data security, and compliance with patient confidentiality. Approved requests will receive data through a secure, controlled-access platform.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

Clinical Trials on Cleft Palate

Clinical Trials on Modified Furlow Palatoplasty combined with buccinator myomucosal flap

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe