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

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

: 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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate, Unilateral, Complete
• Intervention / Treatment: Procedure: furlow z plasty with buccinator myomucosal flap

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 5 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: April 11, 2020
• First Submitted That Met QC Criteria: April 11, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate
• Other Study ID Numbers: Furlow with buccinator

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No