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NCT Number: NCT07514091

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

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.

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Key information

Conditions

Cleft Palate Cleft Lip Cleft Lip, Cleft Alveolus and Cleft Palate Cleft Palate Repair Cleft Palate, Unilateral, Complete Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Velopharyngeal Insufficiency

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Furlow Palatoplasty combined with buccinator myomucosal flap

Procedure

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.

Primary outcomes

  1. 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

  2. VP ratio

    Time frame: 6 months

    this is a ratio calculated by dividing Velar length/Pharyngeal depth.

  3. EVP ratio

    Time frame: 6 months

    This is a ratio calculated by dividing Effective Velar length/Pharyngeal depth

Secondary outcomes

  1. 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

  2. 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)

  3. Nasal emission

    Time frame: 6 months after surgery

    By Perceptual speech evaluation and will be evaluated qualitatively as absent or present.

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Adel Thaalab

CONTACT

[email protected]

+201285568850

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • NewGiza University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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