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Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients

NCT02329509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-12-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate which surgical protocol for treating Unilateral Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure) will have less impact in mid facial growth.

The study hypothesis states that a two stage cleft palate repair , with a late hard palate repair will reduce maxillary growth impairment.

Conditions

  • Unilateral Cleft Lip and Palate
  • Cleft Lip
  • Cleft Palate
  • Developmental Disabilities
  • Restricted Language Development

Interventions

PROCEDURE

two stage palate surgical repair

two stage palate surgical repair with a hard palate closure at 3 to 4 years old

PROCEDURE

One stage Palate Surgical repair

One stage palate repair at the age of 9 to 24 months old

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Professor Fernando Figueira Integral Medicine Institute

    lead OTHER

Principal Investigators

  • Nivaldo Alonso, PH.D · USP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-10-31
Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02329509 on ClinicalTrials.gov