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Cleft Palate Surgery and Speech Development



Cleft Palate Surgery and Speech Development

For Condition: Cleft Palate,Cleft Lip
Status: No longer recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) , University of Sao Paulo
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 475

Location and Contact Information:

University of Florida
Gainesville,  Florida,  32166
United States
 

Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)
Bauru,  Sao Paulo,  17043-900
Brazil
 


Additional Information:
Study ID Numbers:  NIDCR-010;  R01DE10437
Study Start Date: February 1996
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004639

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