Approximately 7000 babies are born with a cleft lip and/or cleft palate in the United States per year. Globally, this defect is staggeringly common, with 100,000 new cases per year. This defect is due to a failure of normal fusion between facial structures, causing a full thickness gap of the upper lip involving skin, muscle, and other connective tissue. Due to aberrant insertion of the muscle underlying the lip as well as abnormal formation of deeper facial structures, the nose is also displaced inferiorly, laterally, and posteriorly. The wider the cleft, the more challenging the repair.

Current best practice in treating unilateral cleft lip and nose deformity involves presurgical infant orthopedics (PSIOs). PSIOs involves presurgically treating the deformity using custom orthodontics to gradually bring the two halves of the cleft together, reducing defect size and enabling complete repair with one surgery during early infancy. However, creation of these molds is time consuming and requires the expertise of a cleft orthodontist and weekly visits to the hospital for device advancement. As not all cleft centers have a specialized cleft orthodontist-including Johns Hopkins Hospital-many are unable to provide presurgical infant orthopedics. Weekly travel to cleft centers can also pose a significant temporal and financial burden to families, as the average patient is located over 60 miles from the nearest cleft center. In a recent survey of cleft centers in the United States, only 30% of these centers are able to provide presurgical orthopedic molding devices in treatment protocols. These centers therefore correct wide clefts with a staged, two-surgery approach. This approach is often less successful in both adequately aligning the gum and in repairing nasal defects, and usually requires intensive orthodontics and additional surgeries in adolescence. As the defect is not fully corrected in infancy, children are additionally subjected to the emotional and psychological difficulty and damage to self-esteem associated with the persistent defect.

With the advent of 3D printing technology, the investigators are now in the planning stages of implementing a new clinical protocol to bring PSIOs to Johns Hopkins Hospital (JHH). A cleft orthodontist at an equipped center will remotely design these orthodontic molds, which will then be 3D printed using dental acrylic (the same material currently used in hand-fabricated orthodontic models) and given to patients in the investigators' clinic. As planning these devices for 3D printing can be done remotely in a fraction of the time it would take to create each one by hand, this change in clinical practice will eliminate the need for an in-person specialized craniofacial orthodontist on faculty where one does not exist.

This research study seeks to elucidate both the investigators' current standard of cleft practice and the benefits the investigators hope to see after implementing this change in clinical practice. The investigators expect that although the investigators will initially create each new mold after a weekly hospital visit with in-person measurements, the investigators ultimately aim to develop an algorithm to predict early growth and development of the newborn's facial skeleton and soft tissue. This will allow the fabrication of sequential pre-surgical orthopedic molding devices based of the infant's predicted facial growth, which can be delivered en bloc to the infants home, thereby eliminating the need for frequent visits to geographically inconvenient centers. After 4-5 months of using these devices, the bony cleft gap will be closed, the nose straightened, and the child be ready for the definitive cleft lip and nose repair in a single surgery. These devices will not only physically close the gap of the cleft lip deformity, but will also close the gap in access to the necessary specialists for the ideal management of cleft deformities across the country. With this technology, any cleft center can offer naso-alveolar molding to every child born with cleft lip and palate in the country.