Legal analysis of information displayed on dental material packages: An exploratory research

Some of the dental materials possess occupational hazards, preprocedural errors, and patient allergies as suggested by evidence. With due consideration to safety of the patients and dental professionals, it is essential that the trade of these materials is in conformity with the law. Aim: To perform the legal analysis of the information displayed on the packaging of dental materials. Materials and Methods: The Bureau of Indian Standards sets guidelines for packaging and marketing of dental products in India. An exploratory cross-sectional study was performed using various search engines and websites to access the laws and regulations existing pertaining to dental materials packaging. Based on the data obtained, a unique packaging standardization checklist was developed. Dental laboratory and impression plasters, alginates, and endodontic instruments were surveyed for all the available brands. This study considered 16 brands of plasters and alginates and 42 brands of endodontic instruments for legal analysis. Legal analysis was performed using the direct observation checklist. Descriptive statistics were obtained using SPSS version 19. Results: The guidelines set by the Bureau of Indian Standards do exist but are not updated and stand as oblivious guards for marketing standards. Overall compliance to the guidelines was reported to be 18.5% by brands of alginates, 4.1% by plaster of Paris, and 11.11% by endodontic instruments. Wave One™ File reported maximum adherence with the guidelines as 66.7%. Conclusion: This study found lower rate of adherence to the guidelines, thus indicating insufficient information being disclosed to the consumers