Various pharmacological treatment approaches, primarily antibiotics, analgesics, and antiseptic agents, are frequently used in the treatment of periodontal diseases. 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. 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. Side effects related to medications prescribed in periodontology clinics are often considered mild or transient, thus limiting systematic feedback based on real-life data. 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.
Study Type
OBSERVATIONAL
Enrollment
571
* It will be classified using the Naranjo algorithm in terms of causality, * It will be evaluated according to the Hartwig-Siegel adverse effect severity scale in terms of severity, * Its impact on quality of life will be measured using a valid and reliable oral health-related quality of life scale (OHIP-14). Sample forms of the Naranjo algorithm, Hartwig-Siegel scale and Quality of Life scale are uploaded as files.
Sivas Cumhuriyet University
Sivas, Turkey (Türkiye)
RECRUITINGNaranjo algorithm results
The results of this algorithm will be recorded according to the medications used.The Naranjo algorithm is a method that allows for the standard and repeatable evaluation of drug-side-effect relationships. For each identified potential drug side effect, the causal relationship between the drug and the side effect will be evaluated using the Naranjo adverse drug reaction probability algorithm. This algorithm consists of 10 questions that inquire about the probability of the side effect being drug-related, and based on the total score obtained, the side effects will be classified as follows: * ≥9 points: Certain * 5-8 points: Possible * 1-4 points: Probable * 0 points: Suspicious
Time frame: 12 months
Hartwig-Siegel Adverse Effect Severity Scale
The Hartwig-Siegel side effect severity scale will be recorded according to the medications used and their side effects.Side effects will be assessed using the Hartwig-Segel side effect severity scale. This scale classifies side effects according to their need for clinical intervention and outcomes. Accordingly, side effects will be grouped as follows: * Mild (Level 1-2): Side effects that do not require treatment change or are controlled with minimal intervention * Moderate (Level 3-4): Side effects that require drug discontinuation, dose change, or additional treatment * Severe (Level 5-7): Side effects that require hospitalization, permanent damage, or are life-threatening.
Time frame: 12 months
Oral Health Impact Profile-14 (OHIP-14).
The impact of drug side effects on quality of life will be recorded using OHIP-14. The impact of drug-related side effects on patients' quality of life will be evaluated using the oral health-related quality of life scale. For this purpose, the OHIP-14 scale, whose validity and reliability have been proven, will be applied. The scale consists of 14 items covering areas such as functional limitations, physical pain, psychological distress, and social disability. Each item will be scored using a Likert-type scale, and an increase in the total score indicates a negative impact on quality of life. The following questions will be answered considering the possible side effects of the drugs prescribed in the periodontology clinic. For scoring; All items are added together. The total score range is 0-56. A higher score indicates that oral health has a greater negative impact on quality of life.
Time frame: 12 months
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