SmileScope – A Baby Bottle Device to Capture Intraoral Images of the Maxillary Palate

Introduction: Cleft palate is a congenital malformation that results from the incomplete fusion of the hard and soft palate. Prior to operative reconstruction, infants undergo nasoalveolar molding (NAM) corrective therapy to non-surgically reposition the palatal tissue and reduce the severity of the cleft opening. To build the artificial palate, a dental impression of the cleft is obtained while holding the baby inverted and pressing the molding material into the maxillary palate and cleft. This process is uncomfortable, highly invasive, hazardous for an infant, and requires frequent visits over the treatment period. Currently NAM treatment is only accessible in higher-income nations where infants can routinely visit specialists.

Modern visualization technologies like dental scanners offer less intrusive methods for intraoral examination, however these scanners primarily cater to adult patient care and at a high price point. The necessity for a pediatric oral assessment technique that is noninvasive, more cost-effective for underprivileged communities, and designed to ensure a positive patient experience inspired the development of SmileScope.

Materials and

Methods: SmileScope is comprised of 3 different subsystems and utilizes photogrammetry to digitize images into a 3D model: the delivery system, the imaging system, and the 3D modeling software. The delivery system consists of a modified bottle designed for feeding infants with a cleft palate. The elongated silicone nipple enables the camera to reach deeper into the oral cavity for imaging the soft palate while gently depressing the tongue. The use of a modified bottle nipple provides a familiar device for infant comfort, is designed to fit into the oral cavity of newborns, and is readily available in low-income communities. The imaging system utilizes a portable, water-resistant, dual lens borescope that can fit within the nipple. Multiple tests were conducted for image quality in dark and wet environments, image distance, field of view, and heat generation during use. A glass straw approved for food and drink consumption is used to stabilize the camera within the body of the bottle. The 3D modeling software Polycam was tested for accuracy, completeness, time, and accessibility.

A preliminary design review was presented to Craniofacial Anomalies Clinic Team at UMass Memorial Children’s Medical Center, Worcester, Massachusetts, for feedback. The final design was tested on a healthy adult according to the WPI IRB protocol IRB-24-0380 (see Figures 1 & 2) and compared to a donated dental scan performed with a 3Shape Trios Scanner.

Results, Conclusions, and Discussions: The SmileScope prototype successfully captured 130 photos in 5 minutes with a digital 3D model of the maxilla created in Polycam in 5 minutes (see Figure 3). The area imaged included the soft palate, hard palate, and posterior gums. The level of detail and structure size proved comparable to the 3Shape model. Pediatric and adult dental models were altered to simulate a cleft and then imaged with all relevant features captured. The size of the nipple remained the same which will allow for use in even premature infants.

Clinician feedback highlighted the need for scanning technology in patient care even in high-income settings to facilitate transfer of care and accuracy of medical records. In terms of NAM creation, the gums also need imaging as a NAM attaches to the gums. Scanning of the gums was not included in the IRB-approved protocol, and therefore not tested at the time of abstract submission. SmileScope combines off-the-shelf hardware with a total price of $170 USD. A Polycam yearly subscription price of $100 USD. The total price is significantly lower than the closest competitor 3Shape Trios at $25,900 USD for the base model.

Other features of the SmileScope include a rechargeable battery and a memory card. These features will enable scanning in low-resource areas to capture the images that can later be sent to trained clinicians for assembly with Polycam and review. Clinicians can then design the NAM that will either be shipped to the patient/local clinician or the design parameters can be sent electronically and built locally. Additionally, SmileScope can be used to assess NAM fit and progress between fittings remotely.

In conclusion, SmileScope coupled with Polycam software can be used to image the palate of infants and create a 3D digital model thus replacing the need for traditional impression molding. The combined price is significantly lower than comparable devices for adults and images can be captured in low-resource settings by individuals with minimal training, which can expand access of care to low-income communities.

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