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| 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 |
| 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 |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| 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 |
| Study First Received: | September 17, 1999 |
| Last Updated: | July 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004639 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Mouth Diseases Cleft Palate Musculoskeletal Diseases Facies Cleft Lip |
Craniofacial Abnormalities Maxillofacial Abnormalities Stomatognathic Diseases Congenital Abnormalities Musculoskeletal Abnormalities |
|
Mouth Diseases Cleft Lip Craniofacial Abnormalities Jaw Diseases Stomatognathic System Abnormalities Maxillofacial Abnormalities Lip Diseases |
Musculoskeletal Abnormalities Cleft Palate Musculoskeletal Diseases Mouth Abnormalities Jaw Abnormalities Stomatognathic Diseases Congenital Abnormalities |
