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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346173
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Hams Hamed Abdelrahman, Alexandria University

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.


Condition or disease Intervention/treatment Phase
Cleft Palate, Unilateral, Complete Procedure: furlow z plasty with buccinator myomucosal flap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Palatal Lengthening Using Buccinator Myomucosal Flaps With Furlow Z-plasty Technique for Primary Cleft Palate Repair (A Clinical Study)
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. palatal lengthening [ Time Frame: immediately postoperative ]
    measuring the length the palate will gain using this technique



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346173


Locations
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Egypt
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Sponsors and Collaborators
Hams Hamed Abdelrahman
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Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer, Alexandria University
ClinicalTrials.gov Identifier: NCT04346173    
Other Study ID Numbers: Furlow with buccinator
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities