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Completed

NCT Number: NCT05196555

Cleft Palate With Intravelar Veloplasty Repair

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

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Key information

Conditions

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

Age range

9 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. change in soft palate elevation

    Time frame: Baseline, immediately after procedure

    Observing the range of motion of soft palate using videofluoroscopy

  2. change in tongue motion assessment

    Time frame: Baseline, immediately after procedure

    Observing the range of tongue motion using videofluoroscopy

  3. change in lips motion assessment

    Time frame: Baseline, immediately after procedure

    Observing the range of lips motion using videofluoroscopy

  4. change in nasal airflow

    Time frame: Baseline, immediately after procedure

    Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2022
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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