Evaluation of Adverse Effects Related to Prescribed Medications in a Periodontology Clinic
Evaluation of Adverse Effects Related to Prescribed Medications in a Periodontology Clinic in Terms of Causality, Severity, and Quality of Life: A Prospective Study
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
-
Sivas, Tyrkiet (Türkiye)
- Rekruttering
- Sivas Cumhuriyet University
-
Kontakt:
- Şükran Acıpınar Asisstan Professor
- Telefonnummer: +905385498141
- E-mail: dtsukranacipinar@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Naranjo algorithm results
Tidsramme: 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:
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hartwig-Siegel Adverse Effect Severity Scale
Tidsramme: 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:
|
12 months
|
|
Oral Health Impact Profile-14 (OHIP-14).
Tidsramme: 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. |
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Ali Kemal YILMAZ
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .