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
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).