Kristen Lowe, DDS, MS, an assistant professor of plastic and reconstructive surgery in the University of Colorado School of Medicine, has received a grant from Align Technologies, the company that makes the Invisalign tooth-straightening system. The grant will support Lowe in developing more efficient ways to treat infants with cleft lip and palate.
Lowe currently treats infants with the congenital craniofacial anomaly — which affects one in 700 individuals worldwide — through a process called nasoalveolar molding (NAM), which uses an orthopedic appliance used to actively mold and reposition nose and mouth tissues before surgery.
“In the first few months of life, we can take a wide cleft and minimize the deformity,” she says. “We bring the gum segments together, the lip segments together, and we shape the noses in these infants in preparation for their first surgical repair, which is traditionally at three to six months of life. The goal is to set up the patient for the best surgical result possible.”
Increasing access
While effective, NAM is currently a laborious process that requires a dental impression be taken of the infant for appliance fabrication, followed by weekly office visits over the course of months for assessment and adjustments by a specially trained orthodontist. In her research funded by Align, Lowe plans to develop a fully digital method for NAM that uses an intraoral scanning device to capture an optical impression of the mouth, and produce a set of 3-D printed NAM devices that can be inserted by parents at home.
“Orthodontic techniques have evolved over the past decade or so, moving toward digital treatment modalities and the use of 3-D printing. It seems logical to utilize this technology to model what I’m doing for these infants on the computer,” she says. “My goal is to make treatment more predictable and accessible to families that aren’t able to come into the office.”
Lowe will use her award to gather pilot data through a single-site clinical trial in order to develop the digital workflows and fabrication method for a digital NAM process.
Early intervention
Patients with cleft lip and palate have problems chewing and speaking, as well as psychosocial challenges and often a significantly lower quality of life. While there are certain risk factors for cleft palate, including maternal age, folic acid deficiency, and smoking and/or alcohol use during pregnancy, in most cases the cause is unknown. July is National Cleft and Craniofacial Awareness and Prevention Month.
Addressing the facial deformity early is important because cartilage is much more moldable in infants from 0 to 6 months old. In addition to setting infants up for successful surgeries, the NAM process also helps infants with cleft lip and palate feed more easily.
“With cleft palate, the soft palate muscles aren't working properly to create suction to allow the infant to feed,” Lowe says. “They cannot breastfeed, but there are specialized bottles that work by compression; milk is expelled as long as the baby or parent compresses the nipple. However, this can be challenging, especially if the cleft is really wide. When you have the appliance in, there’s a hard surface simulating the palate that allows the infant to more easily compress the nipple and feed better.”
Data collection
Lowe is currently enrolling patients in a clinical trial to collect data that will help to streamline and standardize the digital NAM process to make it more accessible and less expensive. To determine the effectiveness of a digital model, a randomized trial will assign newborns diagnosed with cleft lip and palate to either a traditional manual NAM process or a digital, 3-D printed process. All other care will remain constant.
“We expect the final result of this study to show that a digital process is comparable to the traditional process,” she says. “The impact of this result would show that a successful NAM treatment, using our digital process, can be achieved remotely with distributed manufacturing of the 3-D printed appliances and a virtual review of the data to verify the digital treatment plan by a provider. We also expect to show that the digital process is much faster and less expensive.”
