PeriodontitisNCT06973148
Evaluation of Oxidative Stress and Methylated Arginine Levels in Individuals With Periodontitis
An observational study of Periodontitis and Oxidative Stress, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
You are being invited to participate in a scientific research study. Before you decide to take part, it is essential that you understand why the study is being conducted and what your participation will involve. Please take the time to read the following information carefully. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Oxidative Stress
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2021to 19 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of individuals recruited from the Department of Periodontology, Ankara University Faculty of Dentistry, between June 2021 and December 2022.
Who may be able to join
- Having at least 16 natural teeth
- Aged between 18 and 64 years
- Systemically healthy (no known systemic diseases)
Who cannot join
- Having diabetes, cancer, cardiovascular diseases, and/or any autoimmune diseases such as rheumatoid arthritis
- Pregnant and lactating mothers 3-Tobacco users
- Patients using antibiotics, anti-inflammatory medications, immunosuppressive drugs, and contraceptives within three months
- Patients who had periodontal treatment during the last six months
Trial locations and contacts
1 site in 1 country.
About this study
You are being invited to participate in a scientific research study. Before you decide to take part, it is essential that you understand why the study is being conducted and what your participation will involve. Please take the time to read the following information carefully. Feel free to ask if anything is unclear or need more details.
This study aims to evaluate saliva composition, specifically focusing on amino acid and protein building blocks, oxidative stress, and the Nitric Oxide metabolism system, including levels of ADMA (Asymmetric Dimethylarginine) and SDMA (Symmetric Dimethylarginine). By examining these parameters, we aim to contribute to a better understanding of the biological mechanisms involved in gum health and systemic responses.
Read more
You have been selected to participate in this study based on your periodontal (gum) health status. A total of 40 individuals, 20 diagnosed with periodontitis and 20 diagnosed as periodontally healthy, who meet the study criteria, will be included.
If you choose to participate, you will receive non-surgical periodontal treatment as part of your routine care. Before the treatment, biological samples, including saliva and serum, will be collected. These samples will be used solely for scientific analysis and will not affect the outcome of your dental treatment. Although the total duration of the study is 2 years, your involvement will conclude at the beginning of periodontal therapy.
There are no anticipated risks associated with participation beyond those commonly encountered during dental examinations and treatments. You will not benefit directly; however, your contribution will help advance scientific knowledge about the factors influencing oral and systemic health.
All information collected from you during the study will remain confidential. Your identity will be protected, and personal data will not be disclosed in any reports or publications resulting from this study.
Participation in this study is entirely voluntary. You are free to decline or withdraw at any time, without needing to give a reason. Your decision will not affect the quality of care you receive.
All tests, examinations, and procedures performed as part of this study will be provided at no cost to you. Participation will not result in any financial cost or compensation.
Read the detailed description
This scientific research study is designed to investigate the biological components of saliva, with particular attention to specific biomarkers related to gum health and broader systemic functions. The study focuses on evaluating amino acids and protein building blocks in saliva, markers of oxidative stress, and elements of the Nitric Oxide metabolism system. Special emphasis is placed on measuring the levels of Asymmetric Dimethylarginine (ADMA) and Symmetric Dimethylarginine (SDMA), which are known to play roles in vascular and inflammatory processes.
The primary objective is to enhance understanding of the biological mechanisms that underpin periodontal (gum) health and disease, as well as to explore potential systemic interactions. By comparing biological parameters between individuals with periodontitis and those who are periodontally healthy, the study seeks to identify patterns and correlations that may inform both preventive and therapeutic strategies in dental care and possibly broader health contexts.
The study will enroll a total of 40 participants, divided equally between two groups:
- 20 individuals diagnosed with periodontitis.
- 20 individuals diagnosed as periodontally healthy.
- Participants are selected based on their periodontal health status and must meet specific inclusion criteria set by the research team.
Participation Process:
Participants will undergo standard, non-surgical periodontal treatment as part of their regular dental care.
Prior to the commencement of this treatment, biological samples, including saliva and blood serum, will be collected.
These samples are used strictly for scientific purposes and will not interfere with the participants' clinical care or treatment outcomes.
The study itself spans a period of 2 years, but the participants' active involvement is limited to the time up to the start of their periodontal therapy.
Risks and Benefits:
The study is considered low-risk. The procedures involved do not present risks beyond those typically associated with standard dental examinations and treatments.
Participants will not receive direct personal benefit from the study. However, their involvement will significantly contribute to advancing scientific knowledge in the fields of periodontology and systemic health.
Confidentiality and Data Protection:
All information gathered during the study will be handled with strict confidentiality.
Personal identifiers will be removed or coded to ensure anonymity in any reports or publications.
Data protection measures will comply with ethical standards and legal requirements.
Voluntary Participation:
Participation is entirely voluntary. Participants have the right to refuse or withdraw from the study at any point, without providing a reason.
Withdrawal will not affect the standard or quality of care provided.
Financial Considerations:
There is no cost to participants for any procedures or tests carried out as part of the study.
No financial compensation will be provided for participation. In summary, this study is a scientific endeavor aimed at deepening understanding of the biological links between periodontal health and broader systemic markers, with no expected harm or direct benefit to the participants, and with all necessary ethical safeguards in place.
- Conditions
- Periodontitis, Oxidative Stress
- Keywords
- periodontitis, oxidative stress, antioxidante, methylated arginines
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| periodontitis group | Stage III Grade B periodontitis | |
| Healthy group | periodontally healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power analysis
Sample size analysis was performed a priori using G*Power software before the initiation of the study. The analysis applied a large effect size (Cohen's d = 0.8) for independent two-group comparisons, with a significance level (α) of 0.05 and a statistical power of 80%, resulting in a calculated total sample size of 40 participants.
Measured: Baseline
Plaque Index (PI)
Separate intergroup comparisons will be conducted for each clinical outcome measure to allow precise and independent reporting. Thea plaque index (PI), assessed using the Silness and Löe plaque index, which evaluates the thickness of plaque along the gingival margin on a scale from 0 (no plaque) to 3 (abundant plaque). All cl
Measured: Baseline
Probing depth (PD)
The probing depth (PD), measured in millimeters at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a standardized manual periodontal probe (e.g., UNC-15 probe) with markings at 1 mm increments to ensure accuracy.
Measured: Baseline
Bleeding on probing (BOP)
The bleeding on probing (BOP), recorded as the presence or absence of bleeding within 15 seconds of probing at each site and reported as the percentage of positive sites per participant.
Measured: Baseline
Clinical attachment loss (CAL)
Separate intergroup comparisons will be conducted for each clinical outcome measure to allow precise and independent reporting. The clinical attachment loss (CAL), also measured in millimeters at the same six sites per tooth, calculated as the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket.
Measured: Baseline
Determination of salivary and serum oxidative stress index
Total antioxidant status (TAS) and total oxidant status (TOS) were measured at Baseline in saliva and serum samples using Erel's validated method. TAS was based on the reduction of the ABTS⁺ (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid)) radical by antioxidants, causing a decrease in color intensity read at 600 nm with a Varioskan Multimode Reader. Calibration used ascorbic acid; results were expressed in mmol ascorbic acid equivalents/L. Higher TAS indicates stronger antioxidant capacity. TOS involved oxidation of Fe²⁺ to Fe³⁺, forming a colored complex with xylenol orange, read at 530 nm; results were in μmol H₂O₂ equivalents/L. Higher TOS reflects elevated oxidant levels. The oxidative stress index (OSI) was calculated as (TOS/TAS) × 10, a unitless index where higher values indicate greater oxidative stress. All assays were performed in duplicate for reliability.
Measured: Baseline
Determination of Salivary and Serum Methylated Arginine Metabolites
Salivary and serum levels of arginine, asymmetric dimethylarginine (ADMA), and symmetric dimethylarginine (SDMA) were measured at the baseline time point. Quantification was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) with an electrospray ionization (ESI) source (Thermo Scientific Accessmax). Samples underwent protein precipitation and derivatization before injection. Chromatographic separation was achieved on a reversed-phase column under optimized gradient conditions, and mass detection was performed in multiple reaction monitoring (MRM) mode for high specificity. Calibration curves with known standards ensured quantitative accuracy, and results were expressed in micromoles per liter (µmol/L). All measurements were performed in duplicate for reliability.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start7 Jun 2021
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University, Medipol University
- Responsible party
- Principal investigator, Zeliha Guney, Ankara Medipol University
- Investigators
- Zeliha Guney, Principal investigator, Ankara Medipol UniversitySivge Kurgan, Prof., Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973148
- Sponsor's protocol ID
- 04/11
- Other IDs
- 17.02.2021, 04/11
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balkan B, Guney Z, Balkan E, Balkan EP, Kurgan S, Balci N, Serdar MA, Gunhan M. Interaction between methylated arginine metabolites and oxidative stress in periodontitis: a cross-sectional study. BMC Oral Health. 2025 Nov 14;25(1):1781. doi: 10.1186/s12903-025-06972-6.
PubMed 41239382
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxidative Stress and Methylated Arginine Levels in Individuals With Periodontitis
- ClinicalTrials.gov ID
- NCT06973148
- Acronym / sponsor ID
- 04/11
- Conditions
- Periodontitis, Oxidative Stress
- Keywords
- periodontitis, oxidative stress, antioxidante, methylated arginines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Collaborators
- Ankara University, Medipol University
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 15 May 2025 (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.
You are being invited to participate in a scientific research study. Before you decide to take part, it is essential that you understand why the study is being conducted and what your participation will involve. Please take the time to read the following information carefully. Feel free to ask if anything is unclear or need more details.
This study aims to evaluate saliva composition, specifically focusing on amino acid and protein building blocks, oxidative stress, and the Nitric Oxide metabolism system, including levels of ADMA (Asymmetric Dimethylarginine) and SDMA (Symmetric Dimethylarginine). By examining these parameters, we aim to contribute to a better understanding of the biological mechanisms involved in gum health and systemic responses.
You have been selected to participate in this study based on your periodontal (gum) health status. A total of 40 individuals, 20 diagnosed with periodontitis and 20 diagnosed as periodontally healthy, who meet the study criteria, will be included.
If you choose to participate, you will receive non-surgical periodontal treatment as part of your routine care. Before the treatment, biological samples, including saliva and serum, will be collected. These samples will be used solely for scientific analysis and will not affect the outcome of your dental treatment. Although the total duration of the study is 2 years, your involvement will conclude at the beginning of periodontal therapy.
There are no anticipated risks associated with participation beyond those commonly encountered during dental examinations and treatments. You will not benefit directly; however, your contribution will help advance scientific knowledge about the factors influencing oral and systemic health.
All information collected from you during the study will remain confidential. Your identity will be protected, and personal data will not be disclosed in any reports or publications resulting from this study.
Participation in this study is entirely voluntary. You are free to decline or withdraw at any time, without needing to give a reason. Your decision will not affect the quality of care you receive.
All tests, examinations, and procedures performed as part of this study will be provided at no cost to you. Participation will not result in any financial cost or compensation.
Detailed description
This scientific research study is designed to investigate the biological components of saliva, with particular attention to specific biomarkers related to gum health and broader systemic functions. The study focuses on evaluating amino acids and protein building blocks in saliva, markers of oxidative stress, and elements of the Nitric Oxide metabolism system. Special emphasis is placed on measuring the levels of Asymmetric Dimethylarginine (ADMA) and Symmetric Dimethylarginine (SDMA), which are known to play roles in vascular and inflammatory processes.
The primary objective is to enhance understanding of the biological mechanisms that underpin periodontal (gum) health and disease, as well as to explore potential systemic interactions. By comparing biological parameters between individuals with periodontitis and those who are periodontally healthy, the study seeks to identify patterns and correlations that may inform both preventive and therapeutic strategies in dental care and possibly broader health contexts.
The study will enroll a total of 40 participants, divided equally between two groups:
- 20 individuals diagnosed with periodontitis.
- 20 individuals diagnosed as periodontally healthy.
- Participants are selected based on their periodontal health status and must meet specific inclusion criteria set by the research team.
Participation Process:
Participants will undergo standard, non-surgical periodontal treatment as part of their regular dental care.
Prior to the commencement of this treatment, biological samples, including saliva and blood serum, will be collected.
These samples are used strictly for scientific purposes and will not interfere with the participants' clinical care or treatment outcomes.
The study itself spans a period of 2 years, but the participants' active involvement is limited to the time up to the start of their periodontal therapy.
Risks and Benefits:
The study is considered low-risk. The procedures involved do not present risks beyond those typically associated with standard dental examinations and treatments.
Participants will not receive direct personal benefit from the study. However, their involvement will significantly contribute to advancing scientific knowledge in the fields of periodontology and systemic health.
Confidentiality and Data Protection:
All information gathered during the study will be handled with strict confidentiality.
Personal identifiers will be removed or coded to ensure anonymity in any reports or publications.
Data protection measures will comply with ethical standards and legal requirements.
Voluntary Participation:
Participation is entirely voluntary. Participants have the right to refuse or withdraw from the study at any point, without providing a reason.
Withdrawal will not affect the standard or quality of care provided.
Financial Considerations:
There is no cost to participants for any procedures or tests carried out as part of the study.
No financial compensation will be provided for participation. In summary, this study is a scientific endeavor aimed at deepening understanding of the biological links between periodontal health and broader systemic markers, with no expected harm or direct benefit to the participants, and with all necessary ethical safeguards in place.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periodontitis group | – | –Stage III Grade B periodontitis |
| Healthy group | – | –periodontally healthy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of individuals recruited from the Department of Periodontology, Ankara University Faculty of Dentistry, between June 2021 and December 2022.
Key inclusion criteria (3 listed)
- Having at least 16 natural teeth
- Aged between 18 and 64 years
- Systemically healthy (no known systemic diseases)
Key exclusion criteria (4 listed)
- Having diabetes, cancer, cardiovascular diseases, and/or any autoimmune diseases such as rheumatoid arthritis
- Pregnant and lactating mothers 3-Tobacco users
- Patients using antibiotics, anti-inflammatory medications, immunosuppressive drugs, and contraceptives within three months
- Patients who had periodontal treatment during the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Power analysis
Time frame: Baseline
Sample size analysis was performed a priori using G*Power software before the initiation of the study. The analysis applied a large effect size (Cohen's d = 0.8) for independent two-group comparisons, with a significance level (α) of 0.05 and a statistical power of 80%, resulting in a calculated total sample size of 40 participants.
Plaque Index (PI)
Time frame: Baseline
Separate intergroup comparisons will be conducted for each clinical outcome measure to allow precise and independent reporting. Thea plaque index (PI), assessed using the Silness and Löe plaque index, which evaluates the thickness of plaque along the gingival margin on a scale from 0 (no plaque) to 3 (abundant plaque). All cl
Probing depth (PD)
Time frame: Baseline
The probing depth (PD), measured in millimeters at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a standardized manual periodontal probe (e.g., UNC-15 probe) with markings at 1 mm increments to ensure accuracy.
Bleeding on probing (BOP)
Time frame: Baseline
The bleeding on probing (BOP), recorded as the presence or absence of bleeding within 15 seconds of probing at each site and reported as the percentage of positive sites per participant.
Clinical attachment loss (CAL)
Time frame: Baseline
Separate intergroup comparisons will be conducted for each clinical outcome measure to allow precise and independent reporting. The clinical attachment loss (CAL), also measured in millimeters at the same six sites per tooth, calculated as the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket.
Determination of salivary and serum oxidative stress index
Time frame: Baseline
Total antioxidant status (TAS) and total oxidant status (TOS) were measured at Baseline in saliva and serum samples using Erel's validated method. TAS was based on the reduction of the ABTS⁺ (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid)) radical by antioxidants, causing a decrease in color intensity read at 600 nm with a Varioskan Multimode Reader. Calibration used ascorbic acid; results were expressed in mmol ascorbic acid equivalents/L. Higher TAS indicates stronger antioxidant capacity. TOS involved oxidation of Fe²⁺ to Fe³⁺, forming a colored complex with xylenol orange, read at 530 nm; results were in μmol H₂O₂ equivalents/L. Higher TOS reflects elevated oxidant levels. The oxidative stress index (OSI) was calculated as (TOS/TAS) × 10, a unitless index where higher values indicate greater oxidative stress. All assays were performed in duplicate for reliability.
Determination of Salivary and Serum Methylated Arginine Metabolites
Time frame: Baseline
Salivary and serum levels of arginine, asymmetric dimethylarginine (ADMA), and symmetric dimethylarginine (SDMA) were measured at the baseline time point. Quantification was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) with an electrospray ionization (ESI) source (Thermo Scientific Accessmax). Samples underwent protein precipitation and derivatization before injection. Chromatographic separation was achieved on a reversed-phase column under optimized gradient conditions, and mass detection was performed in multiple reaction monitoring (MRM) mode for high specificity. Calibration curves with known standards ensured quantitative accuracy, and results were expressed in micromoles per liter (µmol/L). All measurements were performed in duplicate for reliability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 41239382Balkan B, Guney Z, Balkan E, Balkan EP, Kurgan S, Balci N, Serdar MA, Gunhan M. Interaction between methylated arginine metabolites and oxidative stress in periodontitis: a cross-sectional study. BMC Oral Health. 2025 Nov 14;25(1):1781. doi: 10.1186/s12903-025-06972-6.
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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. This study is not recruiting at the moment.
Zeliha Guney principal investigator
Ankara Medipol University
Sivge Kurgan, Prof. principal investigator
Ankara University
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 Periodontitis and Oxidative Stress, run by Ankara Medipol 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 4 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: finished, as of the sponsor's last update on 15 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power analysis (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06973148, which also lists 1 linked publication.
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 15 May 2025.