Volume 22, Issue 2 (7-2026)
J Health Syst Res 2026, 22(2): 399-401 |
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Research code: مقاله نامه به سردبیر است
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Manochehrifar H, Nekouei A H. The Need for a Dental Material Surveillance System: Lessons from Delayed Failures. J Health Syst Res 2026; 22 (2) :399-401
URL: http://hsr.mui.ac.ir/article-1-2185-en.html
URL: http://hsr.mui.ac.ir/article-1-2185-en.html
1- Assistant Professor, Endodontology Research Center, Kerman University of Medical Sciences, Kerman, Iran
2- PhD Candidate, Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran
2- PhD Candidate, Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran
Abstract: (26 Views)
Despite significant advances in the development and use of dental materials, Iran currently lacks a structured
post-market surveillance system to monitor their safety and effectiveness. Global experience has shown that certain materials reveal their potential risks only after widespread and long-term clinical use. For example, the historical case of Resilon root filling material demonstrated that, despite promising short-term results, long-term cohort studies reported a significantly higher treatment failure rate compared with gutta-percha. Similarly, the use of formaldehyde-containing agents in pulp therapy highlighted the potential for delayed local and systemic toxicity, emphasizing that pre-market evaluations alone cannot fully predict long-term clinical risks. Moreover, the limitations of laboratory testing and small, highly controlled clinical trials prevent comprehensive assessment of real-world performance. Therefore, establishing a “Dental Material Surveillance System”, modeled after pharmacovigilance frameworks, is a critical need. Such a system should include mechanisms for mandatory or incentivized adverse event reporting, a national database for signal detection and follow-up research, requirements for long-term post-market studies of new products, and transparency of information from manufacturers regarding formulation changes and safety reports. Implementing this system would not only enhance patient safety but also improve product quality, inform regulatory decision-making, and strengthen professional trust. This paper discusses the rationale, supporting evidence, and proposed framework for developing such a surveillance system for dental materials in Iran.
Type of Study: Applicable |
Subject:
education health and promotion
Received: 2025/11/21 | Accepted: 2025/11/27 | Published: 2026/07/6
Received: 2025/11/21 | Accepted: 2025/11/27 | Published: 2026/07/6
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