Cleft Palate Surgery and Speech Development

Cleft Palate Clinical Trial

Official title:

Velopharyngeal Function for Speech After Palatal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004639
• Other study ID #: NIDCR-010
• Secondary ID: R01DE010437
• Status: Completed
• Phase: Phase 2
• First received: September 17, 1999
• Last updated: September 16, 2011
• Start date: February 1996
• Est. completion date: April 2007

Study information

• Verified date: June 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00004462

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: April 2007
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Palate

Intervention

Procedure:
• Furlow double z-plasty palatoplasty palate repair

• Von Langenbeck palatoplasty palate repair

Locations

Country	Name	City	State
Brazil	Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)	Bauru	Sao Paulo
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	University of Sao Paulo

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velopharyngeal function for speech was identified to be better for patients who received the Furlow double opposing z-palatoplasty procedure than patients who received the von Langenbeck procedure, as determined by the Cul-de-Sac Test of Hypernasality.		6 months	No