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Cleft Palate Surgery and Speech Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004639
Recruitment Status : Completed
First Posted : September 20, 1999
Last Update Posted : September 20, 2011
University of Sao Paulo
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment Phase
Cleft Lip Cleft Palate Procedure: Furlow double z-plasty palatoplasty palate repair Procedure: Von Langenbeck palatoplasty palate repair Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Velopharyngeal Function for Speech After Palatal Surgery
Study Start Date : February 1996
Actual Primary Completion Date : March 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004639

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32166
Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)
Bauru, Sao Paulo, Brazil, 17043-900
Sponsors and Collaborators
University of Florida
University of Sao Paulo
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Principal Investigator: William N Williams, Ph.D Univerisity of Florida
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Responsible Party: University of Florida Identifier: NCT00004639    
Obsolete Identifiers: NCT00004462
Other Study ID Numbers: NIDCR-010
R01DE010437 ( U.S. NIH Grant/Contract )
First Posted: September 20, 1999    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: June 2011
Keywords provided by University of Florida:
cleft lip and palate
velopharyngeal function
congenital facial malformation
von Langenbeck procedure
Furlow procedure
cleft lip and palate repair
Unilateral cleft lip and palate
Additional relevant MeSH terms:
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Cleft Palate
Cleft Lip
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