Clinical validation of a nanodiamond-embedded thermoplastic biomaterial

Abstract

<p id="d13065785e434">There is a continued need to advance novel nanomedicine platforms into the clinic to address treatment challenges in oncology, infection, and regenerative medicine, among other areas. As such, this work demonstrates the in-human validation of nanodiamonds through their incorporation into gutta percha [nanodiamond-embedded gutta percha (NDGP)], a polymer that repairs root canal treatment sites following tissue disinfection. A randomized, dual-arm clinical trial was implemented, and study endpoints included confirmation of lesion healing, postoperative pain reduction, and the absence of reinfection. To date, the NDGP-treated patients successfully met the study endpoints. Therefore, these findings support the potential expansion of nanodiamonds, and the broader nanomedicine field, into other disease indications. </p><p class="first" id="d13065785e437">Detonation nanodiamonds (NDs) are promising drug delivery and imaging agents due to their uniquely faceted surfaces with diverse chemical groups, electrostatic properties, and biocompatibility. Based on the potential to harness ND properties to clinically address a broad range of disease indications, this work reports the in-human administration of NDs through the development of ND-embedded gutta percha (NDGP), a thermoplastic biomaterial that addresses reinfection and bone loss following root canal therapy (RCT). RCT served as the first clinical indication for NDs since the procedure sites involved nearby circulation, localized administration, and image-guided treatment progress monitoring, which are analogous to many clinical indications. This randomized, single-blind interventional treatment study evaluated NDGP equivalence with unmodified GP. This progress report assessed one control-arm and three treatment-arm patients. At 3-mo and 6-mo follow-up appointments, no adverse events were observed, and lesion healing was confirmed in the NDGP-treated patients. Therefore, this study is a foundation for the continued clinical translation of NDs and other nanomaterials for a broad spectrum of applications. </p>