A Descriptive Observational Study on Materiovigilance of Dental Materials in an Outpatient Department of Dentistry at Government Hospitals in Jaipur

Medical devices are extensively used for the diagnosis, prevention and treatment of different diseases. Even though their use is beneficial to the patients immensely but they also carry significant potential risks. Medical devices are classified into three classes. Dental materials are categorized as Class II medical devices associated with moderate risk according to USFDA.

Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurences associated with the use of medical devices.

Materiovigilance in dentistry is relatively a new concept in India and still in an infancy stage and faces many challenges such as lack of awareness, under reporting, inadequate training and insufficient resources.

Therefore it is of utmost importance to promote and strengthen materiovigilance in Dentsitry, by creating a culture of reporting and encouraging research by generating evidence based data on the safety of medical devices.

Regarding this very few studies have been planned, so this evidence based research will enhance and give an insight into possible device induced Adverse Events with the objective to study and report the adverse events at patient’s first scheduled follow up visit within 3 months period following the use of prosthesis, appliances and materials used in dentistry in a sample size of 150 patients.