Evaluation of Adverse Effects Related to Prescribed Medications in a Periodontology Clinic in Terms of Causality, Severity, and Quality of Life: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 571
- 试验地点
- 1
- 主要终点
- Naranjo algorithm results
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being 16 years of age or older
- •Receiving treatment at a periodontology clinic • Having been prescribed at least one pharmacological agent
- •Volunteering to participate in the study and providing informed consent
排除标准
- •Having a cognitive problem that would prevent the evaluation of side effects related to drug use
- •Patients who did not come for evaluation during the follow-up period or for whom sufficient follow-up data could not be obtained
- •Patients who provided incomplete, inconsistent or unreliable data regarding side effect evaluation
结局指标
主要结局
Naranjo algorithm results
时间窗: 12 months
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
次要结局
- Hartwig-Siegel Adverse Effect Severity Scale(12 months)
- Oral Health Impact Profile-14 (OHIP-14).(12 months)
研究者
Sukran Acipinar
Asisstant Professor
Cumhuriyet University