|Year : 2016 | Volume
| Issue : 2 | Page : 224-230
Legal analysis of information displayed on dental material packages: An exploratory research
Bhumika Rathore1, Pusphpanjali Krishnappa2, Suraj U Mehta2
1 Department of Public Health Dentistry, MNDAV Dental College and Hospital, Solan, Himachal Pradesh, India
2 Department of Public Health Dentistry, Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India
|Date of Web Publication||10-Jun-2016|
Department of Public Health Dentistry, MNDAV Dental College and Hospital, Solan, Himachal Pradesh
Source of Support: None, Conflict of Interest: None
Introduction: 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.
Keywords: Cross-sectional, dental packaging, exploratory research, legal analysis
|How to cite this article:|
Rathore B, Krishnappa P, Mehta SU. Legal analysis of information displayed on dental material packages: An exploratory research. J Indian Assoc Public Health Dent 2016;14:224-30
|How to cite this URL:|
Rathore B, Krishnappa P, Mehta SU. Legal analysis of information displayed on dental material packages: An exploratory research. J Indian Assoc Public Health Dent [serial online] 2016 [cited 2019 Jul 20];14:224-30. Available from: http://www.jiaphd.org/text.asp?2016/14/2/224/183801
| Introduction|| |
In the event of providing care, the profession of dentistry depends and utilizes a wide array of materials. These materials not only pose certain occupational and environmental hazards but also are responsible at times for some preprocedural errors with a significant intangible anxiety caused both to the dentist and the patient. Since these materials are used in the course of providing oral health care, it is essential that the marketing of these also is in conformity with the regulatory framework. Usually, the manufacture and sales of such materials come under the Food and Drug Administration (FDA) of India and the Bureau of Indian Standards, where the law prescribes certain norms and specifications to be adhered to, while manufacturing and marketing these materials.
On search, there are few studies that have reported the adherence to specifications by the dental material manufacturers as per the guidelines. Literature search revealed guidelines and their violation, pertaining to information to be displayed on the packages of dental materials across countries. On literature search, we could access documents published by the Bureau of Indian Standards for the specific information to be displayed in or on the dental material packages,, but not by any other authorities.
Hence, this study was planned with the following objectives: (1) To explore the available guidelines and law pertaining to specifications and standards, if any, for display of information on the packages of dental materials and (2) to perform legal analysis of the information contained in/on the packs of dental materials.
| Materials and Methods|| |
A cross-sectional study was designed and conducted for a period of 4 months from May to August, 2014. The data collection was done over a period of 15 days. Structured and unstructured databases and the websites were accessed, pertaining to the existing regulations and guidelines for the various dental materials packaging.
Based on the information obtained, a direct observation checklist was developed to survey the legal aspects of packaging present on the dental materials. The checklist was based on the guidelines under the FDA and Agencia Nacional de Vigilancia Sanitaria (ANVISA) (National Health Surveillance Agency, Brazil).,,, as maximum number of materials are imported in India. The first part comprised the plaster of Paris and the alginates and the second part comprised the endodontic instruments. The materials were chosen randomly with the intention of filing the research for future records.
For the purpose of recording the checklist and presenting the results, the guidelines for the plasters and alginates were further categorized as physical and chemical properties, chemical composition, minimum testing addressed, precautionary measures, waste disposal, and health risks [Table 1]. Independent guidelines that remained out of categorization in the checklist were brand, indications and methods of use, consistency, and patient acceptance [Appendix 1].
|Table 1: Five domains of the checklist used for plaster of Paris and alginates|
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Endodontic instruments were assessed based on the six guidelines. Guidelines included how to use the instrument as the hand movement is critical for instrument separation, whether the product is sterilized, guidelines for product sterilization, risks involved with the instruments and precautionary measures for the same, criteria and method of disposal indicated for these instruments, and how many times the instrument can be used (single or multiple).
The investigator for the study was calibrated for the use of checklist (κ statistics = 0.98). Nominal scale such as absence and presence of guidelines was recorded in the study tool, since the criteria of unsatisfactory, satisfactory, and absence of information were not clear from the previous literature.
Main dealers of dental materials in Bengaluru city were searched online. All the commercially registered establishments that sell dental products in the city were visited, in the search of different brands and types of dental materials included in the study. Consent was sought from each dealer and confidentiality was assured for the name of the establishment. All types of plaster of Paris, alginates, and endodontic instruments that are manufactured by different companies available in market were surveyed for the study. The registered dealers were contacted for surveying 16 brands of plasters and alginates in total for this study. The five types of plasters and the two types of alginates were included in this study.
The data were obtained directly from observing packages for these materials. Forty-two products of various brands of endodontic instruments that included K-files, H-files, reamers, rotary files, hand Ni–Ti files, broaches, pluggers, spreaders, tungsten carbide burs, diamond burs, and steel burs were surveyed on the basis of ANVISA guidelines. The data collection was scheduled and completed in 10 days. SPSS version 19 (IBM SPSS Statistics for Window, Version 19.0. Armonk, NY: IBM Corp. Released 2011) was used to obtain the descriptive statistics.
| Results|| |
Exploratory research could unveil the set of guidelines for manufacturing and packing of dental materials set by the Bureau of Indian Standards dated on an average to some 40 years back [Table 2]. The documents could be traced for plasters and alginates, but not for the endodontic instruments.
The investigator surveyed 16 brands of plasters and alginates in total. The brand of alginate - tropicalgin showed the maximum compliance with the guidelines with a percentage of 13% of the instructions present on the packaging material and 11.4% (Orthokal) was found to be the highest among plaster of Paris. Overall compliance by alginates was 18.5% and by plasters of Paris was 4.1% [Graph 1] and [Figure 1]. Other guidelines pertaining to health risks, signs of precautions to be used with the material, effectiveness of safety measures, disposal of materials, chemical names in abbreviated form, flavors or colors added, presence of material safety data sheet and the minimum testing addressed forin vitro cytotoxicity, Ame's test for mutagenicity, mucous membrane irritation (Hamster pouch), sensitization test (Guinea Pigs), and carcinogenicity (tumorigenic potential) showed 0% rate of compliance for all brands of plaster of Paris and alginates [Appendix 1].
|Figure 1: Adherence to the packaging guidelines for plaster of Paris and alginates|
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The results for the endodontic instruments had an overall compliance of 11.11% [Table 3]. Wave One ™ File reported the maximum guidelines on packages for the Ni–Ti instruments, i.e., 66.7%. The next highest were the 18 brands which reported a compliance of 16.7%. The other positive 18 results reported a maximum frequency of 16.7%. Poor results were found to be for 42 brands with 0% compliance rates. Among all the endodontic instruments, broaches, pluggers, diamond burs, and steel burs were found to have maximum brands with guidelines, although none had the complete guidelines [Graph 2].
|Table 3: Guideline compliance for the 42 brands of endodontic instruments|
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| Discussion|| |
Information given by the packaging guidelines form a key guide for the end users, and play a vital role in preventing the hazards due to these materials for the dental personnel, patients, and the environment. The research was conducted to explore the available guidelines and laws and to assess the adherence of the information contained in/on the packs of dental materials with the existing regulatory framework. Dental plasters, alginates, and the endodontic instruments were chosen randomly among the dental materials with some evidence of occupational hazards or concern for the patient safety.,
Exploratory research methodology was followed with the help of various search engines and websites. The standards for dental laboratory plasters by the Indian bureau were developed in 1972, revised in 1998, and were presently not notified due to the lack of update for the same. Dental impression plaster standards have been published in 1972 with considerable assistance from the Standards Association of Australia in 1951 and the British Standard Institution from 1970. The docket has been reaffirmed in 1998 without any revision of the previous guidelines with the help of FDA or any other administration department setting up standards for the health care. The marketing specifications in this document do mention name of the product, net weight of the product, manufacturers name and trade mark, and the setting time of the material.
Alginate has been aligned according to the International Organization of Standardization issued in 1978. The statements although not as complete as FDA are quite satisfactory when compared to the dockets for the other dental materials., The literature search gave evidence of the fact that doctor and patient safety are not given a priority when marketing these products. None of the specifications demanded a mention of health risks or allergies. Indications of using materials, physical and chemical properties were outweighed by the instructions for using these materials. The infection control assured or required by the product was also not emphasized by any. No document regarding the packaging guidelines for the endodontic instruments could be traced. Majority of the dental materials are imported in the developing countries. Thus, a universal standardization of materials is a mandate by the agencies such as FDA and ANVISA. However, the exploratory research helped to develop the checklist on the basis of FDA and ANVISA, which can be used for selecting these dental materials manufactured or imported in the country. As these guidelines by these agencies are complete, updated, and previously used for assessment of the different manufacturers for the adherence to the legal guidelines, the checklist can serve universally to standardize all impression materials and endodontic instruments.
We could not find many brands, displaying the safety precautions to be taken by the consumers while using these materials. The risk of allergic dermatitis due to these impression materials was also overlooked by the manufacturers. The materials which directly come in contact with the patient's oral cavity run the risk of allergic stomatitis which could be due to a chemical constituent of the material or due to flavor or color added to the material. Patients who have allergies to shellfish can have an allergic reaction to alginate impression material also., Dental materials causing stomatitis or contact dermatitis are not limited to amalgam, acrylic, composite resins, nickel in prosthetics, and eugenol.
Alginates also showed similar rates of compliance for the samples under study except for the storage qualities, curve of shrinkage, and disposal of materials. Endodontic instruments did not show complete absence of any of the six guidelines among the 42 units of brands. However, individual compliance to the guidelines greatly differed within the different brands. Thus, display of the information in a clear and precise manner regarding the material properties by the manufacturer will help the dentist and the patient in making a safer choice.
However, legal issues ensuring the safety of dentists and the patients are not routinely addressed through research. Thus, the training of the public health dentists in the field of consumer advocacy, hospital administration, and lobby efforts with the various standardizing agencies will help in making the dental practice more safe in terms of legal aspects. The poor compliance of plasters with the guidelines in this study is similar to a study done in Brazil.
Scientific literature from India reported previously includes the investigation of the quality of plaster of Paris manufactured by the Indian companies according to the American and Australian standards for physical properties, but did not confirm with the packaging guidelines as done in the present study and concluded that none of the Indian brands manufactured is suitable for the profession. The products under this study were not divided on the basis of the place of manufacture, as maximum dental materials are imported in India and in accordance to the law, both manufacturing company and importers are responsible for the information about the product being disclosed for the consumers.
Separation of endodontic instruments causes an augmented anxiety both for the dentist and the patient. Such incidences make a dentist restrain their patients from a right to information about the procedural error making themselves more vulnerable to the lawsuits.,
Literature reports incidence of instrument breakage to be maximum for K–files, and laboratory simulation of various clinical methods of handling demonstrated that metal fatigue and damage in the instrument can be spread more severely depending on the type of filing action. Thus, it becomes more important for the packaging to have sufficient guidelines indicating the number of use of such instruments and how to use them.
Infection control is required for invasive procedures in dentistry. Debridement, disinfection, and sterilization need meticulous attention for the endodontic instruments, as a strict infection control leads to better outcomes of the root canal treatment., All endodontic instruments used within the oral cavity should be sterile, have been decontaminated, and sterilized, but the guidelines pertaining to infection control were found to be rare among the range of 42 products of various brands included in the study. These results were similar to the results reported by Silva et al. in 2010.
Infection control and waste disposal are the responsibility for all, as all material which comes in contact with the patient's saliva or blood should be sent for incineration. Gypsum products and hydrocolloids are nonbiodegradable and require disinfection before disposal. Green dentistry is fortified by stringent laws although most of it depends on waste management. Thus, the safe disposal indicated by packaging guidelines will help in a safer and efficient biomedical waste management in dentistry.
| Conclusion|| |
Legal analysis is learning about the existing law and using the same to resolve conflicts in analogous fact situations.
Analysis not only brings out the facts for consumer advocacy of dental materials but also shows possibility of avoiding occupational hazards and preprocedural errors. This present exploratory research elicited the need of guidelines, with the latest standards whenever possible, as inadequate and unrevised laws allow the marketing for substandard and hazardous materials. As results showed a poor compliance with the existing guidelines, standard organizations should make it mandatory for the manufacturers to follow the guidelines recommended by them. The study opens further vistas of research for the all dental materials marketed by the different companies. In addition, materials used in contact with the oral mucosa can be tested microbiologically for their sterilized packaging. Awareness needs to be created among dental surgeons to procure materials that adhere to the guidelines given by the respective authority to ensure the safety of the patients, themselves, and the community at large.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Swann JP. FDA's origin. FDA history office. New York: Oxford University Press; 1998.
Fernandes MM, Mattana R, Mattana C, Reckziegel AP, Ribeiro Tinoco RL, Oliveira RN. Legal analysis of the information contained in dental plaster packs. Braz J Oral Sci 2013;12:223-7.
Kothari CR. Research Methodology. 2nd
ed. New Delhi: New Age International Publishers; 2010.
Guidance for Industry and FDA Staff. Dental Impression Materials – Premarket Notification Document Issued on: August 17, 1998 U.S. Department of Health and Human Services. Food and Drug Administration Center for Devices and Radiological Health Dental Devices Branch Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation; 1998.
Algranti E, Chibante AM. Pneumoconiosis in workers from dental laboratory. Rev Assoc Paul Cir Dent 1993;47:969-72.
Hansen DJ. The Work Environment – Indoor Health Hazards. Health Care Laboratories and Biosafety. Vol. 2. United States: Lewis Publishers; 1993. p. 104.
Casemiro LA, Martins CH, de Souza Fde C, Panzeri H, I to IY. Bacterial, fungal and yeast contamination in six brands of irreversible hydrocolloid impression materials. Braz Oral Res 2007;21:106-11.
Singh R, Singh K, Agrawal KK. A comparative study of physical properties of gypsums manufactured in India. J Indian Prosthodont Soc 2013;13:531-5.
Parashos P, Messer HH. Rotary NiTi instrument fracture and its consequences. J Endod 2006;32:1031-43.
Silva RF. Ethical aspects concerning endodontic instrument fracture. Braz J Oral Sci 2008;7:1535-8.
Sotokawa T. An analysis of clinical breakage of root canal instruments. J Endod 1988;14:75-82.
Linsuwanont P, Parashos P, Messer HH. Cleaning of rotary nickel-titanium endodontic instruments. Int Endod J 2004;37:19-28.
European Society of Endodontology. Quality guidelines for endodontic treatment: Consensus report of the European Society of Endodontology. Int Endod J 2006;39:921-30.
Silva RF, Prado MM, Oliveira HC, Portilho CD, Daruge E Jr. Legal analysis of information about usage instructions present in packs of K file. RSBO 2010;7:200-7.
[Table 1], [Table 2], [Table 3]