Cleft Palate With Intravelar Veloplasty Repair
Primary Purpose
Cleft Palate
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Repair of cleft palate with intravelar veloplasty (IVVP)
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Palate
Eligibility Criteria
Inclusion Criteria:
- Patients with isolated cleft palate age from 9 months to 18 years.
- Patients with submucous cleft.
- Velopharyngeal incompetence (VPI) for palatal re-repair.
Exclusion Criteria:
- Medically unfit patients.
- Syndromic patients with cleft lip and palate.
- Patients with cleft palate associated with multiple congenital anomalies.
- Patients with neurological disorders.
Sites / Locations
- Alexandria Faculty of Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
microscopic surgical repair of cleft palate with intravelar veloplasty (IVVP)
Arm Description
Outcomes
Primary Outcome Measures
change in soft palate elevation
Observing the range of motion of soft palate using videofluoroscopy
change in tongue motion assessment
Observing the range of tongue motion using videofluoroscopy
change in lips motion assessment
Observing the range of lips motion using videofluoroscopy
change in nasal airflow
Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.
Secondary Outcome Measures
Full Information
NCT ID
NCT05196555
First Posted
December 17, 2021
Last Updated
January 5, 2022
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT05196555
Brief Title
Cleft Palate With Intravelar Veloplasty Repair
Official Title
Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
December 17, 2020 (Actual)
Study Completion Date
December 17, 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 repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Sommerlad technique has been described as a more physiological approach, aiming to restore the anatomy of the velum. This technique, often described as radical intravelar veloplasty, has the following distinctive components: a radical retroposition of velar musculature (m. levator veli palatini, m. palatoglossus, and m. palatopharyngeus), combined with minimal dissection of the hard palate, a tensor tenotomy, and the repair of the m. levator sling
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
microscopic surgical repair of cleft palate with intravelar veloplasty (IVVP)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Repair of cleft palate with intravelar veloplasty (IVVP)
Intervention Description
A triangular flap is designed comprising new epithelial tissue which will be turned over to help close the nasal mucosa. Using a single hook, the oral mucosa and gland layer is separated from the muscle layer. Dissection of the greater palatine nerve-vessel bundle. The anterior palatal flap is raised by a curved elevator. The closure of the nasal mucosa and muscle is completed. Dissection of Velo Palatine Levator begins from the posterior rim of muscle and 5 mm from the midline.
Primary Outcome Measure Information:
Title
change in soft palate elevation
Description
Observing the range of motion of soft palate using videofluoroscopy
Time Frame
Baseline, immediately after procedure
Title
change in tongue motion assessment
Description
Observing the range of tongue motion using videofluoroscopy
Time Frame
Baseline, immediately after procedure
Title
change in lips motion assessment
Description
Observing the range of lips motion using videofluoroscopy
Time Frame
Baseline, immediately after procedure
Title
change in nasal airflow
Description
Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.
Time Frame
Baseline, immediately after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with isolated cleft palate age from 9 months to 18 years.
Patients with submucous cleft.
Velopharyngeal incompetence (VPI) for palatal re-repair.
Exclusion Criteria:
Medically unfit patients.
Syndromic patients with cleft lip and palate.
Patients with cleft palate associated with multiple congenital anomalies.
Patients with neurological disorders.
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Cleft Palate With Intravelar Veloplasty Repair
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