NCT00004639

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 1996

Longer than P75 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 17, 1999

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 1999

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 20, 2011

Status Verified

June 1, 2011

Enrollment Period

10.1 years

First QC Date

September 17, 1999

Last Update Submit

September 16, 2011

Conditions

Cleft LipCleft Palate

Keywords

cleft lip and palatechildrenspeechvelopharyngeal functioncongenital facial malformationvon Langenbeck procedureFurlow procedurecleft lip and palate repairUnilateral cleft lip and palate

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Furlow double z-plasty palatoplasty palate repairPROCEDURE
Von Langenbeck palatoplasty palate repairPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32166, United States

Location

Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)

Bauru, São Paulo, 17043-900, Brazil

Location

MeSH Terms

Conditions

Cleft LipCleft PalateSpeech

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesVerbal BehaviorCommunicationBehavior

Study Officials

  • William N Williams, Ph.D

    Univerisity of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 1999

First Posted

September 20, 1999

Study Start

February 1, 1996

Primary Completion

March 1, 2006

Study Completion

April 1, 2007

Last Updated

September 20, 2011

Record last verified: 2011-06

Locations

BR(1)US(1)