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NCT02881606 Clinical Trial

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

Cleft Lip and Palate Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02881606
Other study ID # CEBD-CU-2016-08-184
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date May 2019

Study information
Verified date December 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date May 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 60 Days
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Naso-alveolar molding (NAM)

• Computer aided design NAM (CAD/NAM)

Locations
Country Name City State
Egypt Faculty of Oral and Dental Medicine, Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alveolar alignment Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments 5-6 months
Secondary Nasal and labial esthetics Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap 5-6 months
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