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

Primary Purpose

Cleft Palate, Unilateral, Complete

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
furlow z plasty with buccinator myomucosal flap
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate, Unilateral, Complete

Eligibility Criteria

9 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

furlow z plasty with buccinator myomucosal flap

Arm Description

using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate

Outcomes

Primary Outcome Measures

palatal lengthening
measuring the length the palate will gain using this technique

Secondary Outcome Measures

Full Information

First Posted
April 11, 2020
Last Updated
April 11, 2020
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04346173
Brief Title
Palatal Lengthening Using Buccinator Myomucosal Flaps With Furlow Z-plasty Technique for Primary Cleft Palate Repair
Official Title
Palatal Lengthening Using Buccinator Myomucosal Flaps With Furlow Z-plasty Technique for Primary Cleft Palate Repair (A Clinical Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate, Unilateral, Complete

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
furlow z plasty with buccinator myomucosal flap
Arm Type
Experimental
Arm Description
using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate
Intervention Type
Procedure
Intervention Name(s)
furlow z plasty with buccinator myomucosal flap
Intervention Description
using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate
Primary Outcome Measure Information:
Title
palatal lengthening
Description
measuring the length the palate will gain using this technique
Time Frame
immediately postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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