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Cleft Palate Surgery and Speech Development

This study has been completed.

Sponsors and Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
University of Sao Paulo
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00004639
  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 II

Genetics Home Reference related topics:   Baller-Gerold syndrome    Crouzon syndrome   

MedlinePlus related topics:   Cleft Lip and Palate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Velopharyngeal Function for Speech After Palatal Surgery

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

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

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

Locations
United States, Florida
University of Florida    
      Gainesville, Florida, United States, 32166
Brazil, Sao Paulo
Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)    
      Bauru, Sao Paulo, Brazil, 17043-900

Sponsors and Collaborators

Investigators
Principal Investigator:     William N Williams, Ph.D     Univerisity of Florida    
  More Information


Responsible Party:   University of Florida ( Dr. William N. Williams, Ph.D. )
Study ID Numbers:   NIDCR-010, R01DE10437
First Received:   September 17, 1999
Last Updated:   July 17, 2008
ClinicalTrials.gov Identifier:   NCT00004639
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
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

Study placed in the following topic categories:
Mouth Diseases
Cleft Palate
Musculoskeletal Diseases
Facies
Cleft Lip
Craniofacial Abnormalities
Maxillofacial Abnormalities
Stomatognathic Diseases
Congenital Abnormalities
Musculoskeletal Abnormalities

Additional relevant MeSH terms:
Mouth Abnormalities
Jaw Diseases
Stomatognathic System Abnormalities
Jaw Abnormalities
Lip Diseases

ClinicalTrials.gov processed this record on October 15, 2008




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