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You can access this
clinical trial
if you have
Cleft Lip Palate or Cleft Lip, Unilateral, Complete
and you are
under 30
years old
The phase for this study is not defined.
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The purpose

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).

Provided treatments

  • Device: Nasoalveolar molding therapy
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Tris trial is registered with FDA with number: NCT03029195. The sponsor of the trial is Alexandria University and it is looking for 45 volunteers for the current phase.
Official trial title:
Efficacy of Nasoalveolar Molding Therapy for Treatment of Unilateral Cleft Lip and Palate in Egyptian Infants