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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329509
• Other study ID #: U1111-1158-3755
• Secondary ID: CADEFI /IMIP
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: December 1, 2016
• Start date: January 2010
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• two stage palate surgical repair
two stage palate surgical repair with a hard palate closure at 3 to 4 years old
• One stage Palate Surgical repair
One stage palate repair at the age of 9 to 24 months old

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute	University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maxillary Growth Evaluated by the Atack Yardstick	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	between 4 to 5 years old	Yes