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

Cleft Palate, Unilateral, Complete Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346173
• Other study ID #: Furlow with buccinator
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate
• Cleft Palate, Unilateral, Complete

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	palatal lengthening	measuring the length the palate will gain using this technique	immediately postoperative