Cleft Palate With Intravelar Veloplasty Repair

Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty

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

Study Overview

• Status: Completed
• Conditions: Cleft Palate
• Intervention / Treatment: Procedure: Repair of cleft palate with intravelar veloplasty (IVVP)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: microscopic surgical repair of cleft palate with intravelar veloplasty (IVVP)

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate
• Other Study ID Numbers: Maxillo_2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No