Having a Periodontal PrescriptionNCT07666100
Evaluation of Adverse Effects Related to Prescribed Medications in a Periodontology Clinic
An observational study of Having a Periodontal Prescription, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Having a Periodontal Prescription
- What is being tested?
- questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 571 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2026to 30 Sep 2027
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Sivas
Şükran Acıpınar Asisstan Professor, +905385498141, dtsukranacipinar@gmail.com
About this study
Official 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
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
- Being tested
- questionnaire
- Keywords
- adverseeffect, pharmocovigiliance, Periodontology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start30 Mar 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Having a Periodontal PrescriptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 571 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Acipinar, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666100
- Sponsor's protocol ID
- Ali Kemal YILMAZ
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data can be shared once the study is published.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07666100
- Acronym / sponsor ID
- Ali Kemal YILMAZ
- Conditions
- Having a Periodontal Prescription
- Keywords
- adverseeffect, pharmocovigiliance, Periodontology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 571 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Having a cognitive problem that would prevent the evaluation of side effects related to drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire* 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. | Other | – |
Primary outcome
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
2 secondary outcomes
Hartwig-Siegel Adverse Effect Severity Scale
Time frame: 12 months
Oral Health Impact Profile-14 (OHIP-14).
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No. The data can be shared once the study is published.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Having a Periodontal Prescription, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naranjo algorithm results (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.