New FDA Approved for Non-invasive Pre-Surgical Treatment for Cleft Lip/Palate; As Effective, Yet Significantly Less Expensive
Parents and healthcare professionals who care for more than 4,000 cleft lip/palate babies born each year in the U.S. now have a new non-invasive pre-surgical treatment available that research finds is as effective as the established method, yet significantly less expensive.
The DynaCleft cleft lip and palate treatment device uses an elastomeric band to bridge the cleft segments. Its elastic core applies controlled forces to both lip and palate, while gently conforming to the baby's mouth to accommodate feeding, crying or smiling. Applied topically shortly after birth, the device slowly guides soft tissues and bone of the cleft lip and palate into a better position for repair, making first cleft surgery easier for both surgeon and baby.
Developed in collaboration with cleft teams, DynaCleft saves time, money and most importantly, provides greater comfort for the baby. Used together with a simple nasal elevator hand-fashioned from common clinical materials, the new method makes pre-surgical cleft lip and palate treatment accessible to more newborns and greatly reduces the burden of care for parents.
A study published recently in The Cleft Palate-Craniofacial Journal found the clinical effectiveness of this new topical pre-surgical treatment equal to that of the orthodontic appliance widely considered to be the gold standard of pre-surgical treatment for cleft lip and palate. The randomized, prospective study of babies born between 2007 and 2010 with complete unilateral cleft lip and palate compared the results of cleft width reduction and nasal deformity correction between the NAM-Grayson appliance and the new topical method, and concluded that the combination of DynaCleft with a nasal elevator achieves equivalent results to the NAM (nasoalveolar molding) intra-oral appliance.
Dr. LaQuia Walker, 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, Canada, is the only FDA, EU and Health Canada-approved medical device designed specifically for the pre-surgical treatment of cleft lip and palate.
Source: Canica Design Inc.