Uncovering Risks in Routine Dental Care: A Study on Adverse Events Associated With Dental Devices
Author(s)
JEESA GEORGE1, Adusumilli Pramod Kumar, PhD2, Vibha Shetty, MDS, PhD3, Vivekanandan Kalaiselvan, PhD4.
1Assistant Professor, M S Ramaiah University Of Applied Sciences, Bangalore, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3M S Ramaiah University Of Applied Sciences, Bengaluru, India, 4Indian Pharmacopoeia Commission, Ghaziabad, India.
1Assistant Professor, M S Ramaiah University Of Applied Sciences, Bangalore, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3M S Ramaiah University Of Applied Sciences, Bengaluru, India, 4Indian Pharmacopoeia Commission, Ghaziabad, India.
OBJECTIVES: Dental devices are integral in improving oral health outcomes; however, their utilization is not devoid of risks. Adverse events associated with these devices can undermine patient safety and treatment efficacy. This study was aimed to ascertain the prevalence, severity, causality, and characteristics of adverse events related to dental devices.
METHODS: This prospective observational study was conducted for six months at a tertiary care dental hospital to document, analyze, and classify dental device-related adverse events (DDAEs) using standardized tools.
RESULTS: A total of 6,500 patients who visited the dental outpatient department were observed, during which 584 DDAEs were identified, indicating a prevalence rate of 8.98%. The incidence of DDAEs was higher among females (56%) and was notably observed in 29.46% of the pediatric population and 13.7% of the geriatric population. Most DDAEs were associated with lower-to moderate-risk devices (57.6%), whereas only 6.27% were associated with high-risk dental devices. Serious adverse events accounted for 18% of all the reported DDAEs. A total of 109 dental devices were responsible for at least one DDAE. Causality assessment revealed that 59.5% of the DDAEs were classified as related, 31.9% as probable, and 8.6% as possible. Invasive devices accounted for 50.7% of DDAEs, whereas 15% were attributed to sterile dental devices. In addition, 55.5% of DDAEs were caused by single-use devices.
CONCLUSIONS: This underscores significant safety concerns. Considering the likelihood of identifying more adverse events through extended and systematic monitoring, it is crucial to establish a robust and continuous surveillance mechanism to ensure patient safety and enhance dental device use.
METHODS: This prospective observational study was conducted for six months at a tertiary care dental hospital to document, analyze, and classify dental device-related adverse events (DDAEs) using standardized tools.
RESULTS: A total of 6,500 patients who visited the dental outpatient department were observed, during which 584 DDAEs were identified, indicating a prevalence rate of 8.98%. The incidence of DDAEs was higher among females (56%) and was notably observed in 29.46% of the pediatric population and 13.7% of the geriatric population. Most DDAEs were associated with lower-to moderate-risk devices (57.6%), whereas only 6.27% were associated with high-risk dental devices. Serious adverse events accounted for 18% of all the reported DDAEs. A total of 109 dental devices were responsible for at least one DDAE. Causality assessment revealed that 59.5% of the DDAEs were classified as related, 31.9% as probable, and 8.6% as possible. Invasive devices accounted for 50.7% of DDAEs, whereas 15% were attributed to sterile dental devices. In addition, 55.5% of DDAEs were caused by single-use devices.
CONCLUSIONS: This underscores significant safety concerns. Considering the likelihood of identifying more adverse events through extended and systematic monitoring, it is crucial to establish a robust and continuous surveillance mechanism to ensure patient safety and enhance dental device use.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH267
Topic
Clinical Outcomes, Epidemiology & Public Health, Patient-Centered Research
Topic Subcategory
Public Health
Disease
No Additional Disease & Conditions/Specialized Treatment Areas