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

NCT07666100 | Recruiting

• 1 other identifier: Ali Kemal YILMAZ
• Study Type: observational
• Target: 571
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Having a Periodontal Prescription

Keywords

adverseeffect; pharmocovigiliance; Periodontology

Outcome Measures

Primary Outcomes (1)

• Naranjo 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

  12 months

Secondary Outcomes (2)

• Hartwig-Siegel Adverse Effect Severity Scale

  12 months

• Oral Health Impact Profile-14 (OHIP-14).

  12 months

Interventions

questionnaire OTHER

* 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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who receive treatment at the Department of Periodontology, Faculty of Dentistry, Sivas Cumhuriyet University between March 30, 2026 and September 30, 2027, who meet the inclusion criteria, and who have been prescribed any pharmacological agent will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Professor

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)