Collaborative study faciliates digital workflow for cleft and craniofacial procedure

A recent publication in the Journal of Cleft Lip Palate and Craniofacial Anomalies highlights interdisciplinary work from School of Dentistry providers working to enhance the patient experience with digital workflows.

“Digital fabrication of nasoalveolar molding devices for the treatment of infants with cleft lip and palate” is a proof-of-concept study whose aim was to develop a digital workflow for the creation of nasoalveolar molding (NAM) devices for infants as young as two weeks of age.

This research was “a passion project” for Thorsten Gruenheid, DDS, PhD, MPH, MHA, professor of orthodontics and Assistant Dean for Advanced Education. “I was excited to see our Cleft and Craniofacial Clinic becoming the University’s first NAM clinic. When I learned that providers were using a traditional NAM technique, I believed that there was an opportunity to advance the care into the age of digital dentistry.” 

NAM is “a known therapy to help align both the soft tissue and bony segments to prepare for initial lip and future palate repair,” according to Mackensie McBeain, DDS, associate professor of pediatric dentistry, who performs nasoalveolar molding for all patients in the clinic. 

“NAM can support improved surgical outcomes for infants born with a cleft lip and palate by gradually approximating the alveolar segments and lip, and improving nasal asymmetry,” explained Karla Olesen, BSN, RN, PHN, LDA, nurse coordinator for the Cleft and Craniofacial Clinic.

However, a traditional NAM technique also comes with a significant time burden.

When using a traditional NAM model, patients must first undergo an impression, during which the infant is fully awake. “The impression can pose a potentially life-threatening risk. Patients may become apenic while the impression material sets,” explained Gruenheid. “For this reason, this is usually done with a surgeon or other emergency provider present.” 

After the impression is taken, an acrylic resin splint is made based on a plaster cast base and adjusted weekly in the clinic. This requires significant effort from the provider team, and from the families, who need to come to the clinic weekly for adjustments.

In the study, Gruenheid and McBeain created a digital workflow that used intraoral scanning and computer-aided design to 3D print splints with incremental changes—similar to the process used with clear orthodontic aligners. They scanned the patient and worked with John Madden, Master CDT, to digitally design and create the NAM splints. This allows for a simpler initial mold creation and eliminates the need for weekly returns to the clinic. 

“Our workflow can make NAM treatment more efficient, allowing clinicians to allocate more time for patient care,” explained Gruenheid. “It  can also decrease the burden on patients and their families by reducing the risk associated with impressions, cost and number of visits to adjust the splits. Importantly, with decreasing prices of technology, families who previously could not afford NAM may gain access to care.” 

Olesen, who served as a liaison between the clinical work and research, saw first-hand how this process reduced patient burden during the course of the study. “Before implementing digital scanning, families traveled to the University each week for 30-minute appointments over a period of three to six months,” she explained. “If the digital workflow can reduce that number of visits by half or even a quarter, it would meaningfully alleviate the burden of managing those appointments.” 

This study provides evidence that a digital workflow can successfully be created using commercially-available technologies—and the impact that can have on patients and families is significant.

“It is hard enough navigating life with a newborn, let alone one with craniofacial differences,” reflected McBeain. “Reducing this burden while still allowing them access to such an amazing therapy would open up doors for craniofacial teams across the nation.”