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| Name | Class |
|---|---|
| NewGiza University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cleft palate group | Experimental | Patients undergoing late primary cleft palate repair with Modified Furlow Palatoplasty combined with buccinator myomucosal flap |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 Months |
| VP ratio | this is a ratio calculated by dividing Velar length/Pharyngeal depth. | 6 months |
| EVP ratio | This is a ratio calculated by dividing Effective Velar length/Pharyngeal depth | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months after surgery |
| Hypernasality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina Adel Thaalab | Contact | +201285568850 | dinaadelta3lab@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39953298 | Background | 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. | |
| 36448363 | Background | 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. |
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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.
Beginning 3 months and ending 3 years after the publication of results
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.
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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 | By Perceptual speech evaluation and will be evaluated qualitatively as absent or present. | 6 months after surgery |
| 32976083 | Background | 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. |
| 34393194 | Background | 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. |
| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| D002971 | Cleft Lip |
| D014681 | Velopharyngeal Insufficiency |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008047 | Lip Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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