NCT00004639

Cleft Palate Surgery and Speech Development

Velopharyngeal Function for Speech After Palatal Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cleft Lip
• Cleft Palate

Interventions

Type	Name	Description
PROCEDURE	Furlow double z-plasty palatoplasty palate repair
PROCEDURE	Von Langenbeck palatoplasty palate repair

Timeline

• Start date: 1996-02-01
• Primary completion: 2006-03-01
• Completion: 2007-04-01
• First posted: 1999-09-20
• Last updated: 2011-09-20

Locations

2 sites across 2 countries: United States, Brazil