Evaluating the Safety and Efficacy of Dental Pacifiers through Finite Element Analysis

Case Overview

This case study delves into a scenario involving two pediatric patients who were administered a therapeutic or preventative dental bite (occlusal) pacifier. The brand in question had undergone computational modeling via finite element analysis (FEA) to ascertain its potential benefits or drawbacks before being used on humans.

An expert in FEA was sought to scrutinize the records and the FEA models, and provide an opinion on both the general application of FEA and the specific analysis performed on this type of product.

Questions to the Biomechanical Engineering expert and their responses

Could you describe your experience with finite element analysis (FEA), particularly as it pertains to dental products?

My extensive experience dealing with forensic incident mechanics and injury biomechanics cases, including medical device failures, has equipped me with a deep understanding of FEA.

My background in computational modeling is rooted in fundamental physics that guide the mechanistic approach used to assess or inform the design process. This extends into multiscale realms, offering new insights into the functionality of medical devices like orthopedic and dental implants.

In general terms, what aspects of an FEA analysis would be crucial in determining the validity of the results, and their applicability to the general population for whom the product is intended?

Two key aspects are pivotal for model validation among many essential factors. Macroscale issues involve ensuring that the model accurately reflects anatomical geometries, biomaterial properties, and tissue properties. Microscale issues require each computational element to incorporate appropriate mathematical physics at a continuum scale pertinent to the modeled environment. A clinical model only holds value if validated through experimental, animal, or human testing before release to the general population.

Have you ever reviewed a similar case? If yes, could you please elaborate?

Yes, I routinely handle cases that use models to characterize forensic incidents. I have examined the biomechanical and biomaterial performance of devices as they interface with the biological environment.

My own model development has delved into the subtle mathematics and programming codes associated with the resulting software.

About the expert

This expert has an extensive background in biomechanical engineering, with over 30 years of experience and a specialization in biotechnology. They hold advanced degrees in engineering mechanics and bioengineering, and have contributed significantly to the field through numerous peer-reviewed publications. Currently, they are a clinical research professor of emergency medicine, biomaterials, and biomechanics, as well as an associate professor in plastic and reconstructive surgery at a major medical school, while also leading a biomedical engineering firm.