enCore's Clinical Trials

Background

Proprietary clinical trials are essential for any medical or dental device manufacturer selling directly to consumers. This is particularly true for us here at enCore as we require our buyers to create their own dental impression using our at-home kit. Faulty impression taking techniques could lead to ill-fitting guards, which could fail to provide adequate protection and also exacerbate or create new dental issues. 

With our at-home impression kit, we have placed great emphasis on ease of use and providing clear instructions and video tutorials. We have also made dedicated ongoing support and feedback throughout the whole process our utmost priority. But that alone isn't sufficient given our responsibility as a dental device manufacturer.

The Study

So we here at enCore have designed and conducted studies with the objective of evaluating whether our custom mouth guards are comparable to those one would get fitted for at a dentist. These clinical trials were performed over the course of 6 weeks with a total of 15 subjects.

With the assistance of a licensed dental physician, an upper and lower set of dental impressions were professionally taken from our subjects. The subjects then took their own upper and lower impressions using our very own at-home impression kit. These impressions were then used by us to manufacture two sets of upper/lower guards.

     

Photos of Subject Wearing Guard A (In-Office) and Guard B (At-Home)

The resulting guards were then independently assessed and graded by both the licensed physician and the subjects. Both the physician and subjects were blinded to the impression source used to make the guard. Grades were provided on the following scale: 1) Excellent Fit, no issues; 2) Good Fit, minor cosmetic issues; 3) Good Fit, minor performance issues; 4) Poor Fit.

The Results

All 15 sets of in-office guards were rated Excellent Fit by both the physician and the subject. Correspondingly, all 15 sets of at-home guards were rated as Excellent Fit by both the physician and the subjects.

These results are in line with clinical data represented in the FDA’s MAUDE database*. 

Conclusion

The study demonstrates that at-home, over-the-counter (OTC) impression kits can safely and effectively be utilized to create impressions and guards that match the fit and quality of those made in professional clinical settings. The overwhelmingly positive evaluations, absence of adverse cases, and user satisfaction all substantiate the notion that these kits are a viable alternative to in-office procedures.

Consequently, these findings support the broader adoption of OTC dental solutions and the idea that such products could expand access to more affordable and convenient dental care. This increased accessibility would aid in patient compliance and preventive care for a variety of orthodontic and dental conditions.

*McCracken, Michael S et al. “Impression evaluation and laboratory use for single-unit crowns: Findings from The National Dental Practice-Based Research Network.” Journal of the American Dental Association (1939) vol. 148,11 (2017): 788-796.e4. doi:10.1016/j.adaj.2017.06.015