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Nasoalveolar Molding for Egyptian Cleft Lip Palate Infants (EgyCleft)

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: NCT03029195
Recruitment Status : Active, not recruiting
First Posted : January 24, 2017
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Mona Sabry Mostafa Saad, Alexandria University

Brief Summary:

The cleft lip and palate (CLP) is the commonest craniofacial anomaly worldwide. Nasoalveolar molding (NAM) therapy has emerged in the management of CLP as an early presurgical intervention to provide symmetry to severely deformed nasal cartilage, achieve projection to the flattened nasal tip, provide nonsurgical elevation for the columella, improve alignment of the alveolar ridge, reduce the cleft gap and it could significantly reduce the number of secondary surgeries. Despite that NAM therapy is becoming the treatment option for early cleft care, there is growing debate about its efficacy due to lack of quantitative assessment of these findings. To provide the highest levels of clinical evidence on NAM therapy, there has been international call for Randomized Controlled Clinical Trials.

Statement of the problem: lack of quantitative data about the efficacy of the NAM therapy for unilateral CLP.

Aim of the study: is to develop a standardized non-invasive quantitative assessment for two different techniques of the NAM therapy in Egyptian infants that involves 3D laser scanning/CAD analysis for maxillary geometry, and nasal anthropometric analysis.

Methods Trial design: Prospective randomized controlled clinical trial (RCT). Settings: The RCT will be performed through two phases; (Phase I: A controlled pre and post-RCT that will be designed for the quantitative evaluation of the NAM therapy on the maxillary geometry), and (Phase II: A post-test RCT will be designed for the quantitative evaluation of the NAM therapy on the nasal anthropometry and comparing the outcome with the nasal anthropometry that will be performed to age matched Egyptian norms).

Participants: 30 Egyptian infants with nonsyndromic UCLP will be randomly allocated to study groups (Group I, n=15) that will undergo NAM therapy before the primary surgical repair, and control group (n=15) that will undergo the primary surgical repair without NAM therapy. And 15 Egyptian infants will act as norm group.

Follow-up: (phase I- T0: before NAM, T1: after 1 month and T2: before surgery). (Phase II- T"0: 10 days after surgery, and T"1: 6 months after surgery).

Condition or disease Intervention/treatment Phase
Cleft Lip Palate Cleft Lip, Unilateral, Complete Device: Nasoalveolar molding therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Nasoalveolar Molding Therapy for Treatment of Unilateral Cleft Lip and Palate in Egyptian Infants
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study group
Nasoalveolar molding therapy for cleft lip and palate infants
Device: Nasoalveolar molding therapy
Presurgical infant orthopedics

No Intervention: Control group
No nasoalveolar molding therapy for cleft lip and palate infants
No Intervention: Age matched Norms
Normal (non-cleft) age matched infants

Primary Outcome Measures :
  1. Three dimensional (3D) change in the maxillary geometry. [ Time Frame: (T0 baseline; pre-NAM therapy), (T2 during NAM therapy) and (T3 before surgery) ]
    CAD analysis for the maxillary casts that will be obtained from the cleft infants in both study and control group.

Secondary Outcome Measures :
  1. Change in the nasal anthropometry. [ Time Frame: ( T"0 = 1 days post-surgery) and (T"1= 6 months post-surgery). ]
    Photogrammetric analysis for photographs that will be taken for the cleft infants in both study and control group.

Other Outcome Measures:
  1. Nasal anthropometry of age-matched (6 months old) Egyptian norms. [ Time Frame: ( T"0 = 10 days post-surgery) and (T"1= 6 months post-surgery). ]

    Photogrammetric analysis for photographs that will be taken for the age-matched norm group.

    anthropometry with the Egyptian norms

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Egyptian infants.
  • Infants should present with nonsyndromic complete UCLP ,
  • Infant age should be less than 90 days.
  • The infant's family agreed to undergo NAM therapy.

Exclusion Criteria:

  • Congenital malformations and soft tissue bands.

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): NCT03029195

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Faculty of dentistry, Alexandria University
Alexandria, Egypt
Sponsors and Collaborators
Alexandria University
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Principal Investigator: Mona S. Saad, MSc Alexandria University
Study Data/Documents: Study Protocol  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mona Sabry Mostafa Saad, Lecturer of Prosthodontics, Alexandria University Identifier: NCT03029195    
Other Study ID Numbers: AlexandriaU
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mona Sabry Mostafa Saad, Alexandria University:
cleft lip and palate
nasoalveolar molding
Egyptian infants
quantitative analysis
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities