Periodontal DiseasesNCT07691060
Asprosin and Total Antioxidant/Oxidant Status in Diabetes and Periodontal Disease
An observational study of Periodontal Diseases and Gingival Diseases, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about how different periodontal health status affects the levels of asprosin (a hormone) and total oxidant/antioxidant status in the gingival crevicular fluid and blood serum of individuals with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Gingival Diseases, Type 2 Diabetes
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of adults aged 18-65 years. The gingivitis and periodontitis groups included patients diagnosed with type 2 diabetes mellitus (T2DM), whereas the healthy control group consisted of systemically healthy individuals. Participants were required to be non-smokers, have more than 20 natural teeth, and have no systemic conditions or medication use that could affect the immune response of the periodontal tissues.
Who may be able to join
- Patients with type 2 diabetes mellitus (T2DM) in the gingivitis and periodontitis groups
- Systemically healthy individuals without any systemic disease in the healthy control group
- Age between 18 and 65 years
- Non-smokers
- Individuals with no diseases or medication use that could alter the immune response of the periodontal tissues
- Participants with more than 20 natural teeth
Who cannot join
- Age younger than 18 years or older than 65 years
- Smokers
- Individuals with any disease or medication use that could alter the immune response of the periodontal tissues
- Pregnant women
- Individuals who had received periodontal treatment within the previous 6 months
- Patients with type 1 diabetes mellitus (T1DM)
- Individuals who had used antibacterial medications within the previous 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Türkiye, Gülhane Faculty of Dentistry
Ankara, Ankara, 06100
About this study
Official title: Evaluation of the Effects of Different Periodontal Statuses on Asprosin and Total Oxidant/Antioxidant Levels in Gingival Crevicular Fluid and Serum of Patients With Type 2 Diabetes: A Cross-sectional Study.
The goal of this observational study is to learn about how different periodontal health status affects the levels of asprosin (a hormone) and total oxidant/antioxidant status in the gingival crevicular fluid and blood serum of individuals with Type 2 diabetes.
The main questions it aims to answer are:
Read more
Do individuals with Type 2 diabetes and periodontal disease have different levels of asprosin and oxidative stress markers compared to diabetic individuals with healthy gingiva ?
How do local changes in the gingiva relate to systemic (body-wide) biomarkers in diabetic patients?
Participants with Type 2 diabetes will undergo a routine clinical periodontal examination to evaluate their gingival health. During their regular clinic visit, samples of fluid from around their gingiva (gingival crevicular fluid) and routine blood samples (serum) will be collected to measure and compare these biochemical markers
Read the detailed description
This prospective, observational cross-sectional study aims to investigate the impact of various periodontal conditions on local and systemic levels of asprosin, total oxidant status (TOS), and total antioxidant status (TAS) in individuals with Type 2 diabetes mellitus. The primary objective is to evaluate whether localized periodontal inflammation modulates these specific biochemical markers in the presence of an underlying systemic metabolic condition like diabetes.
Participants diagnosed with Type 2 diabetes mellitus will be recruited from patients visiting the clinic. Based on a comprehensive clinical periodontal examination, participants will be categorized into distinct groups according to their periodontal health status (such as periodontal health, gingivitis, or periodontitis, based on current classification criteria). Clinical periodontal parameters, including probing depth (PD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP), will be recorded for all subjects.
Prior to any clinical measurements or mechanical periodontal treatment, site-specific sampling will be performed. Gingival crevicular fluid (GCF) samples will be collected from selected teeth using paper strips. In addition, routine venous blood samples will be obtained from each participant to separate the serum.
The collected GCF and serum samples will be stored at -80 degrees Celsius until laboratory analysis. Biochemical evaluations will be conducted using Enzyme-Linked Immunosorbent Assay (ELISA) kits to quantify asprosin levels, while spectrophotometric methods will be utilized to determine Total Oxidant Status (TOS) and Total Antioxidant Status (TAS) levels. Statistical analyses will be performed to compare the biomarker levels among the different periodontal groups and to assess the correlations between clinical periodontal parameters and biochemical data.
- Conditions
- Periodontal Diseases, Gingival Diseases, Type 2 Diabetes
- Keywords
- asprosin, periodontitis, gingivitis, total oxidant status, total antioxidant status, oxidative stress
- Medical subject headings
- Periodontal Diseases, Gingival Diseases, Diabetes Mellitus, Type 2, Arachnodactyly, Periodontitis, Gingivitis
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 |
|---|---|---|
| Periodontal health | Systemic and periodontal health participants | |
| Gingivitis | Type 2 Diabetes and gingivitis | |
| Periodontitis | Type 2 Diabetes and periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of serum and gingival crevicular fluid asprosin levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions.
Measured: At a single study visit during enrollment
Secondary outcomes (1)
Comparison of serum and gingival crevicular fluid total oxidant status and total antioxidant status levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions.
Measured: At a single study visit during enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Jul 2025
- Primary completion17 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğuz Koca, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691060
- Sponsor's protocol ID
- 2025-218
- Other IDs
- 2024/077
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator following publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Periodontal Statuses on Asprosin and Total Oxidant/Antioxidant Levels in Gingival Crevicular Fluid and Serum of Patients With Type 2 Diabetes: A Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT07691060
- Acronym / sponsor ID
- 2025-218
- Conditions
- Periodontal Diseases, Gingival Diseases, Type 2 Diabetes
- Keywords
- asprosin, periodontitis, gingivitis, total oxidant status, total antioxidant status, oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 8 Jul 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.
The goal of this observational study is to learn about how different periodontal health status affects the levels of asprosin (a hormone) and total oxidant/antioxidant status in the gingival crevicular fluid and blood serum of individuals with Type 2 diabetes.
The main questions it aims to answer are:
Do individuals with Type 2 diabetes and periodontal disease have different levels of asprosin and oxidative stress markers compared to diabetic individuals with healthy gingiva ?
How do local changes in the gingiva relate to systemic (body-wide) biomarkers in diabetic patients?
Participants with Type 2 diabetes will undergo a routine clinical periodontal examination to evaluate their gingival health. During their regular clinic visit, samples of fluid from around their gingiva (gingival crevicular fluid) and routine blood samples (serum) will be collected to measure and compare these biochemical markers
Detailed description
This prospective, observational cross-sectional study aims to investigate the impact of various periodontal conditions on local and systemic levels of asprosin, total oxidant status (TOS), and total antioxidant status (TAS) in individuals with Type 2 diabetes mellitus. The primary objective is to evaluate whether localized periodontal inflammation modulates these specific biochemical markers in the presence of an underlying systemic metabolic condition like diabetes.
Participants diagnosed with Type 2 diabetes mellitus will be recruited from patients visiting the clinic. Based on a comprehensive clinical periodontal examination, participants will be categorized into distinct groups according to their periodontal health status (such as periodontal health, gingivitis, or periodontitis, based on current classification criteria). Clinical periodontal parameters, including probing depth (PD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP), will be recorded for all subjects.
Prior to any clinical measurements or mechanical periodontal treatment, site-specific sampling will be performed. Gingival crevicular fluid (GCF) samples will be collected from selected teeth using paper strips. In addition, routine venous blood samples will be obtained from each participant to separate the serum.
The collected GCF and serum samples will be stored at -80 degrees Celsius until laboratory analysis. Biochemical evaluations will be conducted using Enzyme-Linked Immunosorbent Assay (ELISA) kits to quantify asprosin levels, while spectrophotometric methods will be utilized to determine Total Oxidant Status (TOS) and Total Antioxidant Status (TAS) levels. Statistical analyses will be performed to compare the biomarker levels among the different periodontal groups and to assess the correlations between clinical periodontal parameters and biochemical data.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontal health | – | –Systemic and periodontal health participants |
| Gingivitis | – | –Type 2 Diabetes and gingivitis |
| Periodontitis | – | –Type 2 Diabetes and periodontitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults aged 18-65 years. The gingivitis and periodontitis groups included patients diagnosed with type 2 diabetes mellitus (T2DM), whereas the healthy control group consisted of systemically healthy individuals. Participants were required to be non-smokers, have more than 20 natural teeth, and have no systemic conditions or medication use that could affect the immune response of the periodontal tissues.
Key inclusion criteria (6 listed)
- Patients with type 2 diabetes mellitus (T2DM) in the gingivitis and periodontitis groups
- Systemically healthy individuals without any systemic disease in the healthy control group
- Age between 18 and 65 years
- Non-smokers
- Individuals with no diseases or medication use that could alter the immune response of the periodontal tissues
Key exclusion criteria (7 listed)
- Age younger than 18 years or older than 65 years
- Smokers
- Individuals with any disease or medication use that could alter the immune response of the periodontal tissues
- Pregnant women
- Individuals who had received periodontal treatment within the previous 6 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
Comparison of serum and gingival crevicular fluid asprosin levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions.
Time frame: At a single study visit during enrollment
1 secondary outcome
Comparison of serum and gingival crevicular fluid total oxidant status and total antioxidant status levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions.
Time frame: At a single study visit during enrollment
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 8 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator following publication of the study results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontal Diseases and Gingival Diseases, run by Saglik Bilimleri Universitesi 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 6 inclusion and 7 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 8 Jul 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?
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?
Comparison of serum and gingival crevicular fluid asprosin levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions. (time frame: At a single study visit during enrollment). 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 8 Jul 2026.