Cleft Palate Surgery and Speech Development

This study has been completed.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00004639
First received: September 17, 1999
Last updated: September 16, 2011
Last verified: June 2011
  Purpose

Compare the outcome of two primary surgeries techniques (von Langenbeck and Furlow double z-plasty) performed on children with cleft lip/palate to determine if one results in significantly better velopharyngeal competency for speech.


Condition Intervention Phase
Cleft Lip
Cleft Palate
Procedure: Furlow double z-plasty palatoplasty palate repair
Procedure: Von Langenbeck palatoplasty palate repair
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Velopharyngeal Function for Speech After Palatal Surgery

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Velopharyngeal function for speech was identified to be better for patients who received the Furlow double opposing z-palatoplasty procedure than patients who received the von Langenbeck procedure, as determined by the Cul-de-Sac Test of Hypernasality. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 475
Study Start Date: February 1996
Study Completion Date: April 2007
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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 major emphasis will focus on assessment of the near and long term outcomes of the palatal surgeries on velopharyngeal function for speech.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004639

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32166
Brazil
Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)
Bauru, Sao Paulo, Brazil, 17043-900
Sponsors and Collaborators
University of Florida
University of Sao Paulo
Investigators
Principal Investigator: William N Williams, Ph.D Univerisity of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00004639     History of Changes
Obsolete Identifiers: NCT00004462
Other Study ID Numbers: NIDCR-010, R01DE10437
Study First Received: September 17, 1999
Last Updated: September 16, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Florida:
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

Additional relevant MeSH terms:
Cleft Lip
Cleft Palate
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities

ClinicalTrials.gov processed this record on August 19, 2014