A cross-sectional study on knowledge, attitudes, practices, and barriers related to materiovigilance among resident doctors of government dental hospital, Rajasthan, India.

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Title: A cross-sectional study on knowledge, attitudes, practices, and barriers related to materiovigilance among resident doctors of government dental hospital, Rajasthan, India.
Authors: Sharma, Jaya (AUTHOR), Jain, Monica (AUTHOR), Sharma, Kopal (AUTHOR)
Source: Journal of Oral Research & Review. Jan-Jun2026, Vol. 18 Issue 1, p1-6. 6p.
Subjects: Adverse health care events, Awareness, Attitude (Psychology), Residents (Medicine), Dental equipment, Safety, Human behavior
Geographic Terms: Rajasthan (India), Jaipur (India), India
Abstract: Background: According to the United States Food and Drug Administration, dental devices or materials are classified into Class II Medical devices based on risk. While these devices are essential in delivering effective patient care, their use may also be associated with certain risks, including adverse events. To monitor and manage such risks, the Materiovigilance (MV) Program was launched in India. However, the related level of awareness and the reporting practices among the dental professionals remain underexplored. The study sought to explore the levels of knowledge, attitude, and practice, along with the barriers experienced by dental residents regarding adverse events of various dental devices and materials as they fall under the aegis of MV Programme of Government of India. Materials and Methods: An observational and cross-sectional study was executed at a Government-run Tertiary Care Teaching Dental Hospital situated in Jaipur city involving 42 Resident Doctors. A validated 29-item tool was used to evaluate participants' knowledge, attitude, practice, and perceived barriers regarding MV. Results: Among the 42 respondents, 52.3% reported being aware of the MV Program of India. A majority (92.8%) agreed that adverse event reporting should be included in the dental curriculum. Although 74% had encountered device-related adverse events during clinical postings, reporting practices were low. All participants acknowledged lack of training as a major barrier to reporting. Conclusion: The study highlights the urgent necessity of implementing targeted workshops, Continuing Medical Education Programs, and structured reporting mechanisms to foster a culture of MV in dentistry. Enhancing awareness through regular training and curriculum integration is essential to ensure the safe use of dental devices in clinical practice. [ABSTRACT FROM AUTHOR]
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Database: Psychology and Behavioral Sciences Collection
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Abstract:Background: According to the United States Food and Drug Administration, dental devices or materials are classified into Class II Medical devices based on risk. While these devices are essential in delivering effective patient care, their use may also be associated with certain risks, including adverse events. To monitor and manage such risks, the Materiovigilance (MV) Program was launched in India. However, the related level of awareness and the reporting practices among the dental professionals remain underexplored. The study sought to explore the levels of knowledge, attitude, and practice, along with the barriers experienced by dental residents regarding adverse events of various dental devices and materials as they fall under the aegis of MV Programme of Government of India. Materials and Methods: An observational and cross-sectional study was executed at a Government-run Tertiary Care Teaching Dental Hospital situated in Jaipur city involving 42 Resident Doctors. A validated 29-item tool was used to evaluate participants' knowledge, attitude, practice, and perceived barriers regarding MV. Results: Among the 42 respondents, 52.3% reported being aware of the MV Program of India. A majority (92.8%) agreed that adverse event reporting should be included in the dental curriculum. Although 74% had encountered device-related adverse events during clinical postings, reporting practices were low. All participants acknowledged lack of training as a major barrier to reporting. Conclusion: The study highlights the urgent necessity of implementing targeted workshops, Continuing Medical Education Programs, and structured reporting mechanisms to foster a culture of MV in dentistry. Enhancing awareness through regular training and curriculum integration is essential to ensure the safe use of dental devices in clinical practice. [ABSTRACT FROM AUTHOR]
ISSN:22494987
DOI:10.4103/jorr.jorr_19_25