Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial

Cairo University1 site in 1 country28 target enrollmentDecember 2016

ConditionsCleft Lip and Palate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cleft Lip and Palate
Sponsor: Cairo University
Enrollment: 28
Locations: 1
Primary Endpoint: Alveolar alignment
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

May 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cairo University

Responsible Party

Principal Investigator

Noha Ali El Ashmawi

Assistant lecturer at orthodontic department

Cairo University

Eligibility Criteria

Inclusion Criteria

•Bilateral cleft lip and palate

Exclusion Criteria

•Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)