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Search / Trial NCT00004639

Cleft Palate Surgery and Speech Development

Launched by UNIVERSITY OF FLORIDA · Sep 17, 1999

Trial Information

Current as of July 04, 2025

Completed

Keywords

Cleft Lip And Palate Children Speech Velopharyngeal Function Congenital Facial Malformation Von Langenbeck Procedure Furlow Procedure Cleft Lip And Palate Repair Unilateral Cleft Lip And Palate

ClinConnect Summary

This study is conducted with patients with complete unilateral cleft lip and palate. The subjects will have their palatal clefts surgically repaired by either the von Langenbeck or the Furlow double z-plasty palatoplasty. Patients will be randomly assigned to four groups, to have with the von Langenbeck palatoplasty with intravelar veloplasty or the Furlow double opposing z-plasty palatoplasty between 9 and 12 months of age or between 15 and 18 months of age. Lip repair will be randomized to either the Spina or Millard method and will be accomplished by six months prior to palatoplasty. The...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Unrepaired unilateral cleft lip and palate
  • Lip repair surgery to be accomplished by 3-6 months of age
  • Able to return to research site at least once a year for follow-up
  • Exclusion Criteria:
  • Patients with concomitant conditions (ie. mental retardation, deafness)
  • Patients with Simonart Band of the cleft
  • Patients who could not return to research site on a yearly basis

About University Of Florida

The University of Florida, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials. With a focus on enhancing patient outcomes and exploring new therapeutic avenues, the university leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous research across a variety of medical fields. Committed to ethical standards and patient safety, the University of Florida fosters collaboration among researchers, healthcare professionals, and community stakeholders to translate scientific discoveries into impactful clinical applications.

Locations

Gainesville, Florida, United States

Bauru, Sao Paulo, Brazil

Patients applied

0 patients applied

Trial Officials

William N Williams, Ph.D

Principal Investigator

Univerisity of Florida

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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