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Cleft PalateNCT07514091

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

A study testing Modified Furlow Palatoplasty combined with buccinator myomucosal flap in people with Cleft Palate and Cleft Palate, Unilateral, Complete, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 years and older
What is being tested?
Modified Furlow Palatoplasty combined with buccinator myomucosal flap
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteEgypt
Study dates
Jun 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dina Adel Thaalab contact

+201285568850

dinaadelta3lab@gmail.com

Egypt1 site

  • Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Modified Furlow Palatoplasty combined with buccinator myomucosal flap
Keywords
cleft palate, cleft palate repair, velopharyngeal insufficiency, magnetic resonance imaging
Medical subject headings
Cleft Palate, Cleft Lip, Velopharyngeal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Furlow Palatoplasty combined with buccinator myomucosal flapProcedure or surgery

    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.

Study groups in NCT07514091
Study groupRoleWhat they receive
Cleft palate groupExperimentalPatients undergoing late primary cleft palate repair with Modified Furlow Palatoplasty combined with buccinator myomucosal flap
Receives: Procedure: Modified Furlow Palatoplasty combined with buccinator myomucosal flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Velopharyngeal assessment

    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

    Measured: 6 Months

  2. VP ratio

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

    Measured: 6 months

  3. EVP ratio

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

    Measured: 6 months

Secondary outcomes (3)

  1. Speech intelligibility

    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

    Measured: 6 months after surgery

  2. Hypernasality

    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)

    Measured: 6 months after surgery

  3. Nasal emission

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

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07514091
Sponsor's protocol ID
MRI-VPI-FURL-BMF
Status last verified
Oct 2025
First submitted
28 Mar 2026
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • MacIsaac MF, Elsamna SL, Quintana JF, Rottgers SA, Halsey JN. MRI assessment of velopharyngeal dysfunction: A comprehensive primer for radiologists. Pediatr Radiol. 2025 May;55(6):1088-1104. doi: 10.1007/s00247-025-06180-y. Epub 2025 Feb 14.

    PubMed 39953298

  • Perry JL, Snodgrass TD, Gilbert IR, Sutton BP, Baylis AL, Weidler EM, Tse RW, Ishman SL, Sitzman TJ. Establishing a Clinical Protocol for Velopharyngeal MRI and Interpreting Imaging Findings. Cleft Palate Craniofac J. 2024 May;61(5):748-758. doi: 10.1177/10556656221141188. Epub 2022 Nov 30.

    PubMed 36448363

  • Haenssler AE, Fang X, Perry JL. Effective Velopharyngeal Ratio: A More Clinically Relevant Measure of Velopharyngeal Function. J Speech Lang Hear Res. 2020 Nov 13;63(11):3586-3593. doi: 10.1044/2020_JSLHR-20-00305. Epub 2020 Sep 25.

    PubMed 32976083

  • Aboulhassan MA, Aly TM, Akram Khodir MM, Moussa HM, Hussein MA. Quantitative Evaluation of Palatal Lengthening After Cleft Palate Repair When a Buccal Flap Is Routinely Combined With Furlow's Z-Plasty. Ann Plast Surg. 2022 Mar 1;88(3):288-292. doi: 10.1097/SAP.0000000000002964.

    PubMed 34393194

Questions about this trial

What is this clinical trial studying?

A study testing Modified Furlow Palatoplasty combined with buccinator myomucosal flap in people with Cleft Palate and Cleft Palate, Unilateral, Complete, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dina Adel Thaalab (+201285568850, dinaadelta3lab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Velopharyngeal assessment (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07514091, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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