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Cleft Palate With Intravelar Veloplasty Repair

Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05196555
Enrollment
30
Registered
2022-01-19
Start date
2019-08-06
Completion date
2020-12-17
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate

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

Interventions

PROCEDURERepair 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.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Months to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
change in soft palate elevationBaseline, immediately after procedureObserving the range of motion of soft palate using videofluoroscopy
change in tongue motion assessmentBaseline, immediately after procedureObserving the range of tongue motion using videofluoroscopy
change in lips motion assessmentBaseline, immediately after procedureObserving the range of lips motion using videofluoroscopy
change in nasal airflowBaseline, immediately after procedureUsing Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026