Clinical trials are the basis for the development and marketing of new drugs and medical devices. When studying new chitosan-based medical devices, the necessity of a clinical trial depends on the Class of the medical device and the country of registration (EU/US market). In a clinical trial, participants receive specific interventions according to a research protocol to demonstrate the safety and effectiveness of the device compared to a control (placebo or current standard). Drug studies are performed in phase I to phase IV, while medical device studies are classified as pilot, pivotal and post-approval study. Find out more about currently registered clinical trials with chitosan-based products and outcomes of completed trials in the following articles.
Dental, bacterial diseases such as periodontitis can lead to tooth and bone loss. In the study presented here, chitosan, gelatine and Scutellariae baicalensis radix were combined to form a hydrogel to produce an anti-inflammatory implant using 3D bioprinting.