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

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.

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Key information

Conditions

Unilateral Cleft Lip and Palate Cleft Lip Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Developmental Disabilities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mental Disorders Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Neurodevelopmental Disorders Restricted Language Development Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

two stage palate surgical repair

Procedure

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

One stage Palate Surgical repair

Procedure

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Professor Fernando Figueira Integral Medicine Institute

Other

Collaborators

University of Sao Paulo

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2016
First posted: Dec 31, 2014
Registry last updated: Dec 2, 2016

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.

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