Cleft Palate Surgery and Speech Development

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.

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Key information

Conditions

Cleft Lip Behavior Cleft Palate Communication Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Speech Stomatognathic Diseases Stomatognathic System Abnormalities Verbal Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC), Bauru, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furlow double z-plasty palatoplasty palate repair

Procedure

Von Langenbeck palatoplasty palate repair

Procedure

Primary outcomes

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.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

University of Sao Paulo

Registry information

Official study title

Velopharyngeal Function for Speech After Palatal Surgery

Important dates

Study start: 1996
Primary completion: 2006
Study completion: 2007
First posted: Sep 20, 1999
Registry last updated: Sep 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed