Improving the treatment of infants with cleft li

Kristen LoweDDS, MS, Assistant Professor of plastic and reconstructive surgery in the University of Colorado School of Medicine, received a grant from Align Technologies, the company that makes the Invisalign teeth straightening system. The grant will help Lowe develop more effective ways to treat infants with cleft lip and palate.

Lowe currently treats infants with the congenital craniofacial anomaly – which affects one in 700 people worldwide – through a process called nasoalveolar molding (NAM), which uses a brace that is used to actively mold and reposition tissue in the nose and mouth before surgery.

“In the first few months of life, we can take a wide slit and minimize the deformity,” she says. “We gather the gum segments, the lip segments, and we shape the nose of these infants in preparation for their first surgical repair, which is traditionally between three and six months of life. The goal is to prepare the patient for the best possible surgical outcome.

Increase access

Although effective, NAM is currently a laborious process that requires a dental impression of the infant to fabricate the appliance, followed by weekly office visits over the months for evaluation and adjustments by a specially trained orthodontist. In his Align-funded research, 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 an array of 3D-printed NAM devices that can be inserted by parents at home.

“Orthodontic techniques have evolved over the past decade, moving towards digital treatment modalities and the use of 3D printing. It makes sense to use this technology to model what I do for these infants on the computer,” she says. “My goal is to make treatment more predictable and accessible to families who can’t get to the office.”

Lowe will use its award to collect pilot data through a single-site clinical trial to develop the digital workflows and manufacturing 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. Although there are some risk factors for cleft palate, including maternal age, folic acid deficiency, and tobacco and/or alcohol use during pregnancy, in most cases the cause is unknown.

It is important to treat facial deformity early because the cartilage is much more malleable in infants 0-6 months. In addition to preparing infants for successful surgeries, the NAM process also helps infants with cleft lip and palate feed more easily.

“With a cleft palate, the muscles of the soft palate don’t work properly to create suction for the infant to feed,” says Lowe. “They can’t breastfeed, but there are specialized bottles that work by compression; milk is expelled as long as the baby or parent squeezes the nipple. However, this can be tricky, especially if the slot is really wide. When you have the device inside, there is a hard surface simulating the palate which makes it easier for the infant to compress the nipple and suckle better.

Data gathering

Lowe is currently enrolling patients in a clinical trial to collect data that will help 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 3D-printed digital process. All other care will remain constant.

“We hope that the end result of this study will show that a digital process is comparable to the traditional process,” she says. “The impact of this result would show that successful NAM processing, using our digital process, can be achieved remotely with distributed manufacturing of the 3D printed devices and virtual data review to verify the digital processing plan by a vendor. We also hope to show that the digital process is much faster and cheaper.”

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Christine E. Phillips