Cleft Palate With Intravelar Veloplasty Repair

Not Applicable

Completed

• Conditions: Cleft Palate
• Interventions: Procedure: Repair of cleft palate with intravelar veloplasty (IVVP)

• Registration Number: NCT05196555
• Lead Sponsor: Hams Hamed Abdelrahman

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-06
• Primary Completion: 2020-12-17
• Study Completion: 2020-12-17
• Study First Submitted: 2021-12-17
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-19
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
microscopic surgical repair of cleft palate with intravelar veloplasty (IVVP)	Repair of cleft palate with intravelar veloplasty (IVVP)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt