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 University28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cleft Lip and Palate

Interventions

Naso-alveolar molding (NAM)DEVICE

Computer aided design NAM (CAD/NAM)DEVICE

Eligibility

Sex: ALLMin age: 7 DaysMax age: 60 Days

Medical Language ↔ Plain English

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)

Locations (1)

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

Alveolar alignment

Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments

Time frame: 5-6 months

Secondary Outcomes

Nasal and labial esthetics

Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap

Time frame: 5-6 months

Data from ClinicalTrials.gov

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