Completed

Velopharyngeal Function for Speech After Palatal Surgery

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What is being tested

Furlow double z-plasty palatoplasty palate repair

+ Von Langenbeck palatoplasty palate repair

Procedure
Who is being recruted

Congenital Abnormalities+16

+ Behavior

+ Communication

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 1996
See protocol details

Summary

Principal SponsorUniversity of Florida
Last updated: September 20, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00004639NCT00004462
Principal SponsorUniversity of Florida
Last updated: September 20, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

475 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesBehaviorCommunicationJaw AbnormalitiesJaw DiseasesLip DiseasesMouth AbnormalitiesStomatognathic DiseasesMouth DiseasesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVerbal BehaviorStomatognathic System AbnormalitiesCraniofacial AbnormalitiesMaxillofacial AbnormalitiesCleft LipCleft PalateSpeech

Criteria

3 inclusion criteria required to participate
Able to return to research site at least once a year for follow-up
Lip repair surgery to be accomplished by 3-6 months of age
Unrepaired unilateral cleft lip and palate
3 exclusion criteria prevent from participating
Patients who could not return to research site on a yearly basis
Patients with Simonart Band of the cleft
Patients with concomitant conditions (ie. mental retardation, deafness)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Florida

Gainesville, United StatesOpen University of Florida in Google Maps

Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)

Bauru, Brazil
Completed2 Study Centers