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	Treatment or Intervention	Phase
Cleft Lip Cleft Palate	Procedure: Furlow double z-plasty palatoplasty palate repair  Procedure: Von Langenbeck palatoplasty palate repair  Procedure: Spina lip repair  Procedure: Millard lip repair	Phase II

Further Study Details: 

Expected Total Enrollment:  475

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.

Genders Eligible for Study:  Both

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

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

Study ID Numbers:  NIDCR-010; R01DE10437
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  September 17, 1999
ClinicalTrials.gov Identifier:  NCT00004639
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08