Palatal Lengthening Using Buccinator Myomucosal Flaps With Furlow Z-plasty Technique for Primary Cleft Palate Repair

Study Overview
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Brief Summary
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: Cleft palate is a congenital deformity caused by abnormal facial development during intra-uterine life. Worldwide, the prevalence of cleft lip/palate is about 1:1000 live births. The levator vela palatini muscles are malpositioned sagittally, running postero-anteriorly and inserted onto the posterior edge of the hard palate in cleft palate patients . This configuration prevents the muscle from exerting its upward, backward, and lateral pull. Various modalities have been described with major refinements over the past 30 years. Gradually, cleft surgeons began to appreciate the importance of dissection and retro-positioning of the levator muscle on improving speech outcomes. Furlow was the first to describe the palatoplasty technique, in which the levator muscle is dissected and freely released from its abnormal position and retro-positioned in a Z-plasty lengthening technique without dissection on the hard palate. However , among the problems that have been raised concerning the Furlow palatoplasty is the limitation of the procedure in wide clefts. Furthermore, the possibility of higher fistula rate associated with the technique. These considerations have led to modified palatal lengthening by buccinator myomucosal flaps which is this study working on.

Official Title
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Palatal Lengthening Using Buccinator Myomucosal Flaps With Furlow Z-plasty Technique for Primary Cleft Palate Repair (A Clinical Study)

Conditions
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Cleft Palate, Unilateral, Complete

Intervention / Treatment
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* Procedure: furlow z plasty with buccinator myomucosal flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in the age frame between 9 months and 18 months. Cleft palate alone or cleft lip and palate patients. Patients who have not done any previous palatal repair Haemoglobin level above 10 grams. Weight above 10 pounds. Exclusion Criteria: Syndromic patients. Medically compromised patients contradicting operation.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: furlow z plasty with buccinator myomucosal flap<br>using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate | Procedure: furlow z plasty with buccinator myomucosal flap<br>* using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| palatal lengthening | measuring the length the palate will gain using this technique | immediately postoperative |