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

Not Applicable

Completed

• Conditions: Cleft Palate, Unilateral, Complete
• Interventions: Procedure: furlow z plasty with buccinator myomucosal flap

• Registration Number: NCT04346173
• Lead Sponsor: Mahmoud Akram

Brief Summary

: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-03-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-11
• Study First Submitted QC: 2020-04-11
• Study First Posted: 2020-04-15
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
furlow z plasty with buccinator myomucosal flap	furlow z plasty with buccinator myomucosal flap	using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate

Primary Outcome Measures

Name	Time	Method
palatal lengthening	immediately postoperative	measuring the length the palate will gain using this technique

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt