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

NCT02329509 | Completed DMC

• 2 other identifiers: U1111-1158-3755CADEFI /IMIP
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

operative procedures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

one stage cleft palate surgery

ACTIVE COMPARATOR

Subjects submitted to one stage palate surgical repair after 9 months old and before 24 months old ,

Procedure: One stage Palate Surgical repair

two stage palate repair

ACTIVE COMPARATOR

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

Interventions

two stage palate surgical repair PROCEDURE

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

two stage palate repair

One stage Palate Surgical repair PROCEDURE

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

one stage cleft palate surgery

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead
• University of Sao Paulo: collaborator

MeSH Terms

Conditions

Cleft Lip; Cleft Palate; Developmental Disabilities

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nivaldo Alonso, PH.D

  USP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CADEFI Coordinator

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: September 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-12