Recruiting

NCT Number: NCT07666100

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

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.

Recruiting

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Key information

Conditions

Having a Periodontal Prescription

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Location status: Recruiting

Location contact

Şükran Acıpınar Asisstan Professor

CONTACT

[email protected]

+905385498141

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Naranjo algorithm results

Time frame: 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

Secondary outcomes

Hartwig-Siegel Adverse Effect Severity Scale

Time frame: 12 months
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.
Oral Health Impact Profile-14 (OHIP-14).

Time frame: 12 months

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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 24, 2026
Registry last updated: Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.