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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
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate

Eligibility Criteria

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

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

First Posted
December 17, 2021
Last Updated
January 5, 2022
Sponsor
Hams Hamed Abdelrahman
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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

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Cleft Palate With Intravelar Veloplasty Repair

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