Cleft Palate With Intravelar Veloplasty Repair

NCT05196555 | Completed

• 1 other identifier: Maxillo_2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Repair of cleft palate with intravelar veloplasty (IVVP) PROCEDURE

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.

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

Eligibility Criteria

• Age: 9 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with isolated cleft palate age from 9 months to 18 years.
• Patients with submucous cleft.
• Velopharyngeal incompetence (VPI) for palatal re-repair.

You may not qualify if:

• Medically unfit patients.
• Syndromic patients with cleft lip and palate.
• Patients with cleft palate associated with multiple congenital anomalies.
• Patients with neurological disorders.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 19, 2022
• Study Start: August 6, 2019
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

EG (1)