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 University (CU)

Status: Completed

Conditions: Cleft Lip and Palate

Treatments: Device: Computer aided design NAM (CAD/NAM); Device: Naso-alveolar molding (NAM)

Study type: Interventional

Funder types: Other

Identifiers

NCT02881606

CEBD-CU-2016-08-184

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 7 to 60 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Naso-alveolar molding (NAM)

Active Comparator group

Description:

Active plates and nasal stents (Grayson method)

Treatment:

Device: Naso-alveolar molding (NAM)

Computer aided design NAM (CAD/NAM)

Active Comparator group

Description:

Computer aided design active plates and nasal stents

Treatment:

Device: Computer aided design NAM (CAD/NAM)