Invisalign for cleft palate? Researchers team up to bring birth defects treatment home

Just as Invisalign® plastic aligners revolutionized orthodontic treatment, a team from University of Colorado Anschutz Medical Campus hopes his project using 3D-printed plastic molds can transform cleft lip and palate care.

Birth defects, which occur when tissues in an infant’s lip or mouth do not come together properly during pregnancy, occur in one in every 700 births worldwide. The cause is unknown, but it is thought to be a combination of genetic and environmental factors.

The CU Anschutz team is developing a new method for creating a nasoalveolar cast (NAM), which is the first step in today’s standard treatment for cleft lip and palate. The team includes Nicholas Jacobson, researcher in translational clinical design at Inworks, Kristen LoweDDS, MS, Assistant Professor of operation to University of Colorado School of Medicineand Aimee Kim, master’s student in Modern human anatomy.

The process uses an intra-oral scanning device to capture a digital impression of the infant’s mouth, from which a NAM is created and begins a six-month process of alignment in the malleable tissues of the palate, gums and teeth. lips that can be done at home.

Only NAM clinic in the six-state area

“Essentially, it’s like a brace for an infant’s mouth, but it’s a piece of plastic that molds and shapes their mouth properly in the first six months,” Jacobson said. Treatment eliminates or greatly reduces surgical procedures to repair the birth defect. However, the treatment requires weekly clinic visits for six months after NAM placement for checkups and adjustments.

The CU Anschutz team is developing a new method for creating a nasoalveolar cast, which is the first step in today’s standard treatment for cleft lip and palate.

CU Anschutz is the only clinic in a six-state region to offer the NAM treatment, which means some of Lowe’s patients come from as far away as Montana for weekly checkups.

“What we’re trying to do is turn this into a digital process where we can take a simple scan of an infant’s mouth and 3D print all of these NAM devices, allowing parents to insert them at home. “, said Jacobson. “That way, people who live far away can still access this treatment.”

Given the small number of NAM treatment centers around the world, there are millions of craniofacial orthodontic patients – including in developing countries where clefts are one of the most common birth defects – who could benefit from ‘streamlined home treatment,’ Jacobson said.

Use of stop-motion technology

The CU Anschutz team is collaborating with LAIKA Studios, an Oscar-winning stop-motion animation company, on technology that scans the geometry of the mouth in the creation of custom aligners. Additionally, the team has received grants from Align Technologies, the company behind Invisalign®, and Smile Train, the world’s largest non-profit organization supporting cleft palate and lip treatments and research.

“We are in the process of collecting information on palatal growth and creating the digital modeling software,” Jacobson said. “Then, in about a year, we will do a clinical trial of the actual device.”

He says he understands the possible reluctance of parents of newborns to participate in such a clinical trial. Registered infants would have their mouths scanned a day or two after birth.

“I’d like to let them know that this is a well-supported project — both by the university and by industry-leading partners — and that we’re doing everything we can to help them,” Jacobson said.

AB Nexus project: improving surgical outcomes

In another project, Jacobson teamed up with Robert McCurdyPhD, Assistant Professor of Mechanical Engineering at CU Boulder, as part of the inaugural group of funded grant Nexus AB initiative. The project focused on creating preoperative planning models. 3D printed models give surgeons patient-specific visualization interaction patterns with the goal of improving surgical outcomes.

About AB Nexus

Nexus AB, an initiative launched in 2020, provided $2 million to 30 cross-campus collaborative teams comprised of scientists, engineers, and physicians from CU Boulder and the CU Anschutz Medical Campus. The program has proven to be a catalyst in bringing researchers together to tackle innovative projects, allowing them to gather the data needed to succeed in their quest for extramural funding from the NIH and other funding agencies.

For the next phase of the AB Nexus project – the team has applied for continuation funding – researchers plan to develop personalized, biocompatible heart valves and heart stents.

Currently, physicians and surgeons “have no say in their own tools” as valves and stents are pre-made, off-the-shelf components, leaving room for customization for individual patients, Jacobson said. “We’re looking to create a set of patient-specific implants where we can customize a device to fit each person – through 3D printing, new materials, and a new printing process.”

MacCurdy’s team classified the materials as biocompatible and built a new 3D printer that prints using the materials.

Personalized treatment for heart defects

At CU Anschutz, Jacobson, whose team also received a Gates Grubstake price, collaborated with the Jacot Laboratory for Pediatric Regenerative Medicine on cyto- and haemo-compatibility experiments. They grew cells on valves and stents to understand how they work in the heart. “We’re going to start animal trials this fall to verify what we think is an effective material,” Jacobson said.

After this step, researchers can get closer to personalized treatment of heart defects.

“We design our entire workflow around medical imaging,” Jacobson said. “It’s adapted directly to a CT scan or an MRI, and we consult heavily with the surgeon, who is very involved in the process, which is also new. That would be the process: we get the imaging from the medical team, we make the device to specifications, it’s checked by the medical team and implanted. »

Christine E. Phillips