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New FDA approved pre-surgical treatment for cleft lip/palate
Date:12/12/2013

lker, a pediatric dentist with the Riley Hospital for Children at IU Health's Craniofacial Anomalies Team in Indianapolis, says her team uses the DynaCleft® plus nasal elevator method in their protocol because they believe the burden of care on parents of cleft babies is too high with the NAM method. The NAM requires continuous adjustments over a three-to-six month period, so parents must commit to bringing their baby in weekly for custom shaping of the appliance by a specially-trained orthodontist. The time and out-of-pocket expenses required simply to attend appointments can be prohibitive for many families.

"Although NAM therapy is considered to be one of the most effective forms of pre-surgical orthopedics, it is also one of the most costly and time-consuming," says Dr. Walker. "NAM is a labor-intensive technique that requires frequent visits to our craniofacial center over several months. Such requirements can be problematic for many parents who commonly travel great distances as well as having other responsibilities that cannot be put on hold during these first crucial months of the infant's life."

According to the study's lead author Dr. Luis Monasterio, a specialist with more than 40 years experience treating cleft lip and palate babies, this new topical technique may also make babies happier. In the published study, he described the experience of wearing an intra-oral orthodontic appliance from a newborn baby's perspective: "If I was an infant with complete unilateral cleft lip and palate, and soon after my birth someone would place an appliance inside my mouth, a nasal antenna which would obstruct my nasal passage, and cover around my mouth with paper tape, I would certainly not be a happy baby."

The DynaCleft® device, developed by Canica Design Inc. in Ottawa, Ontario is the only FDA, EU and Health Canada-approved me
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SOURCE Canica Design Inc.
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