Cleft Palate Clinical Trial
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
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
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