Clinical Research Directory

Evaluation of Adverse Effects Related to Prescribed Medications in a Periodontology Clinic

Sponsor: Cumhuriyet University

Summary

Various pharmacological treatment approaches, primarily antibiotics, analgesics, and antiseptic agents, are frequently used in the treatment of periodontal diseases (1). While these drugs are important for the clinical effectiveness of periodontal treatment, drug-related side effects can negatively impact patient compliance, quality of life, and overall patient safety, and in some cases, may lead to premature termination of treatment (2). Early identification of drug-related side effects, assessment of causality, and classification of severity form the basis of pharmacovigilance practices. In this context, the Adverse Event Reporting System (FAERS), run by the United States Food and Drug Administration (FDA), is an important data source for detecting drug-related side effects and presenting safety signals. Large databases like FAERS draw attention to potential drug-related side effects and provide valuable information on drug safety. However, this data is largely based on patient/user or physician feedback, and these systems are insufficient to assess the true frequency, clinical severity, and impact on patients' quality of life of side effects (3). Side effects related to medications prescribed in periodontology clinics are often considered mild or transient, thus limiting systematic feedback based on real-life data (4). Therefore, systematic and patient-centered clinical studies using standard algorithms and scales based on real-life data are needed. This study aims to determine the frequency of side effects related to medications prescribed in a periodontology clinic over an 18-month period and to evaluate them according to gender and age. As a secondary aim, it aims to evaluate the causal relationship of these side effects with the medications, their clinical severity, and their impact on patients' quality of life related to oral health using a holistic approach. This will ensure that not only the presence of side effects but also clinical and patient-centered outcomes are presented in an objective, standardized, and reproducible manner.

Official title: Evaluation of Adverse Effects Related to Prescribed Medications in a Periodontology Clinic in Terms of Causality, Severity, and Quality of Life: A Prospective Study

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