Cleft Palate Surgery and Speech Development

NCT ID: NCT00004639

Last Updated: 2011-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-02-29

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cleft Lip Cleft Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Furlow double z-plasty palatoplasty palate repair

Intervention Type PROCEDURE

Von Langenbeck palatoplasty palate repair

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William N Williams, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)

Bauru, São Paulo, Brazil

Site Status

Countries

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United States Brazil

Other Identifiers

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R01DE010437

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDCR-010

Identifier Type: -

Identifier Source: org_study_id

NCT00004462

Identifier Type: -

Identifier Source: nct_alias

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