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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02881606
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : December 3, 2019
Information provided by (Responsible Party):
Noha Ali El Ashmawi, Cairo University

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.

Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Device: Naso-alveolar molding (NAM) Device: Computer aided design NAM (CAD/NAM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Blinding was done for the plastic surgeon (care provider) during lip repair and for the outcome assessor
Primary Purpose: Treatment
Study Start Date : December 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Naso-alveolar molding (NAM)
Active plates and nasal stents (Grayson method)
Device: Naso-alveolar molding (NAM)
Active Comparator: Computer aided design NAM (CAD/NAM)
Computer aided design active plates and nasal stents
Device: Computer aided design NAM (CAD/NAM)

Primary Outcome Measures :
  1. Alveolar alignment [ Time Frame: 5-6 months ]
    Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments

Secondary Outcome Measures :
  1. Nasal and labial esthetics [ Time Frame: 5-6 months ]
    Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02881606

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Faculty of Oral and Dental Medicine, Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
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Responsible Party: Noha Ali El Ashmawi, Assistant lecturer at orthodontic department, Cairo University Identifier: NCT02881606    
Other Study ID Numbers: CEBD-CU-2016-08-184
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities