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

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ClinicalTrials.gov Identifier: NCT02329509
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : December 2, 2016
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Rui Manuel Rodrigues Pereira, Professor Fernando Figueira Integral Medicine Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Unilateral Cleft Lip and Palate Cleft Lip Cleft Palate Developmental Disabilities Restricted Language Development Procedure: two stage palate surgical repair Procedure: One stage Palate Surgical repair Not Applicable

Detailed Description:

The study is being conducted at CADEFI- Centro de Atenção aos Defeitos da Face do IMIP (craniofacial center) in IMIP-Instituto de Medicina Integral Professor Fernando Figueira-, Recife PE- Pernambuco-, Brazil. All children were and will be operated by the same plastic surgeon in the operating room in IMIP. The sample size was calculated in 64 patients, 32 to GI ( one stage repair) and 32 to GII ( two stage repair, with a hard palate late closure), considering taking a statistical power of 90% with a 5% significance, determined with a difference of at least 25% between the two groups. Note : this sample was calculated for the dependent variable commonly present in patients with unilateral lip and palate cleft : atresia of the dental arches.

The groups are numbered in post op care attendance of the lip repair, according to randomization sequence done in computerized statistical program. The randomization is being held after the first month of the lip repair surgery. The surgeon, and parents or guardians (who have already signed the Informed Consent Form) will not have prior access to information on the type of allocation in each group. Subsequently it will be added in patients chart the record set for the patient group.

>Study Variables Independent variables:. Group I (palate closure in two surgical times and GII (closure of the palate in a surgical time) also will be considered independent variables age, sex, birth weight and maternal education.

Dependent variables: the presence of postoperative infection, initial and intermediate cleft sizes, dimensional changes of the transverse arch, the evaluation indexes of dental arch relationship(Goslom,Atack Yardsticks) and speech outcomes evaluation grades

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients. A Prospective Randomized Trial
Study Start Date : January 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: one stage cleft palate surgery
Subjects submitted to one stage palate surgical repair after 9 months old and before 24 months old ,
Procedure: One stage Palate Surgical repair
One stage palate repair at the age of 9 to 24 months old

Active Comparator: two stage palate repair
Subjects submitted to two stage palate surgical repair (first soft palate repair between 6 and 12 months old and hard palate closure at 3 to 4 years old)
Procedure: two stage palate surgical repair
two stage palate surgical repair with a hard palate closure at 3 to 4 years old




Primary Outcome Measures :
  1. Maxillary Growth Evaluated by the Atack Yardstick [ Time Frame: between 4 to 5 years old ]
    A system that evaluates facial growth , assessing dental arch relationships, and ranking them from 1 to 5, being 1 the best and 5 the worst outcome.Cases are allocated to these categories on a value judgment basis by reference to the anchor groups of the Atack Yardstick. This is performed by external judges, previously trained and evaluated



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with unilateral cleft lip and palate admitted consecutively in CADEFI-IMIP between August 1, 2011 and July 31, 2015

Exclusion Criteria:

  • Patients with associated syndromes that retard the neuro-psycho-motor and speech development;
  • Patients without clinical conditions for performing the surgical chronology protocol;
  • Patients whose parents or guardians who are not in accordance with the Informed Consent Statement proposed by the researcher

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329509


Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
University of Sao Paulo
Investigators
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Study Director: Nivaldo Alonso, PH.D USP
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Responsible Party: Rui Manuel Rodrigues Pereira, CADEFI Coordinator, Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier: NCT02329509    
Other Study ID Numbers: U1111-1158-3755
CADEFI /IMIP ( Other Identifier: CADEFI/IMIP )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Keywords provided by Rui Manuel Rodrigues Pereira, Professor Fernando Figueira Integral Medicine Institute:
operative procedures
Additional relevant MeSH terms:
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Cleft Palate
Cleft Lip
Developmental Disabilities
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Neurodevelopmental Disorders
Mental Disorders