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