Cleft Palate With Intravelar Veloplasty Repair

Cleft Palate Clinical Trial

Official title:

Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05196555
• Other study ID #: Maxillo_2021
• Status: Completed
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: December 17, 2020

Study information

• Verified date: January 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 17, 2020
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Procedure:
• Repair of cleft palate with intravelar veloplasty (IVVP)
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.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in soft palate elevation	Observing the range of motion of soft palate using videofluoroscopy	Baseline, immediately after procedure
Primary	change in tongue motion assessment	Observing the range of tongue motion using videofluoroscopy	Baseline, immediately after procedure
Primary	change in lips motion assessment	Observing the range of lips motion using videofluoroscopy	Baseline, immediately after procedure
Primary	change in nasal airflow	Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.	Baseline, immediately after procedure