Cleft Palate Surgery and Speech Development

Completed · Phase 2

Conditions studied: Cleft Lip, Cleft Palate

In brief

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.

Key facts

Study ID

NCT00004639

Run by

University of Florida

People needed

475

Starts

1996-02-01

Expected to finish

2007-04-01

Last updated by the study team

2011-09-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States
• Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC) — Bauru, São Paulo, Brazil

Full record on ClinicalTrials.gov

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