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
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|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|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|
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
- 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
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
|Study Director:||Nivaldo Alonso, PH.D||USP|