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Primary Cleft Lip and Nasal Repair With and Without Nasoalveolar Molding: A Prospective Multicenter Study

Roberto Flores, MD1, Sean Clouston, PhD2, Richard Kirschner, MD3, Judah Garfinkle, DDS4, Barry H. Grayson, DDS1, Court B. Cutting, MD1, Lacey Sischo, PhD5, Ceib Phillips, PhD6, Hillary Broder, PhD5.
1NYU Langone Medical Center, New York, NY, USA, 2Stony Brook School of Medicine, Stony Brook, NY, USA, 3Ohio State University Medical Center, Columbus, OH, USA, 4Oregon Heath and Science University, Portland, OR, USA, 5NYU School of Dentistry, New York, NY, USA, 6Univeristy of North Carolina School of Dentistry, Chapel Hill, NC, USA.

PURPOSE: We present a prospective, multicenter study comparing outcomes of primary cleft lip and nasal reconstruction with and without NasoAlveolar Molding (NAM).
METHODS: 110 infants with cleft lip/palate prospectively studied through six high-volume cleft centers. Study participants were non-randomized to undergo NAM prior to primary repair (n=62) or NO-NAM (n=48). Caregivers rated the severity of their child’s deformity using the Extent of Difference Scale (EOD) preoperatively and at one year of age. Standardized photographs of 54 randomly selected study patients were rated by a blinded expert surgeon using the EOD scale. RESULTS: Caregivers of NAM patients reported greater improvement in their child’s appearance compared to caregivers of NO-NAM patients (p<0.05). This improvement was most apparent in the nose: the NO-NAM group showed no significant improvement in the nose over time (B=-0.19, P=0.299) while the NAM group showed a three-fold greater improvement over time (B=-0.58, P=0.007).
Expert clinician ratings indicated that NAM-treated infants had facial deformities of greater severity at pretreatment (p<0.05). In addition there was greater improvement in appearance after surgery in NAM-treated patient. This difference was most evident in the nose (B=-0.52, p=0.025). There was no statistical difference in postoperative appearance between the NAM and NO-NAM group by clinician rating.
CONCLUSION: NAM provides significantly greater improvement in facial appearance after primary cleft lip and nasal repair compared to patients who undergo NO-NAM.


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