Nasoalveolar Molding for Egyptian Cleft Lip Palate Infants (EgyCleft)
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|ClinicalTrials.gov Identifier: NCT03029195|
Recruitment Status : Active, not recruiting
First Posted : January 24, 2017
Last Update Posted : January 18, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03029195
|Faculty of dentistry, Alexandria University|
|Principal Investigator:||Mona S. Saad, MSc||Alexandria University|