PeriodontitisNCT07703345
Salivary Apelin, Chemerin, Ghrelin, and Lipocalin-2 Levels in Diabetic Patients With Periodontitis
An observational study of Periodontitis and Type 2 Diabetes Mellitus (T2DM), run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This observational cross-sectional study will evaluate salivary apelin, chemerin, ghrelin, and lipocalin-2 levels in individuals with different periodontal and systemic conditions. Participants will be divided into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Salivary Biomarker Analysis
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Aug 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of individuals aged 18 to 80 years who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, meet the eligibility criteria, and agree to participate. Participants will be categorized into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus: periodontally healthy systemically healthy individuals, periodontally healthy individuals with type 2 diabetes mellitus, systemically healthy individuals with periodontitis, and individuals with both periodontitis and type 2 diabetes mellitus.
Who may be able to join
- Individuals aged 18 to 80 years. Individuals who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University.
- Individuals who agree to participate in the study and sign the informed consent form.
- Presence of at least 20 teeth. For the periodontally healthy groups: diagnosis of periodontal health based on routine clinical and radiographic examination.
- For the periodontitis groups: diagnosis of generalized Stage II or Stage III periodontitis based on routine clinical and radiographic examination according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.
- For the type 2 diabetes mellitus groups: diagnosis of type 2 diabetes mellitus. For the systemically healthy groups: absence of systemic diseases, including type 2 diabetes mellitus.
Who cannot join
- Periodontal treatment, including scaling and root surface debridement, within the last 6 months.
- Antibiotic use within the last 6 months. Pregnancy or lactation. Presence of autoimmune diseases such as rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behçet disease, or psoriasis.
- Presence of systemic diseases other than type 2 diabetes mellitus in the diabetes groups.
- Presence of systemic diseases such as nephrotic syndrome, chronic renal disease, or cardiovascular disease.
- Smoking 10 or more cigarettes per day.
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
Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology
Konya, Konya, 42090
Osman Babayiğit, +90 506 320 84 74, obabayigit@erbakan.edu.tr
About this study
Official title: Evaluation of Salivary Apelin, Chemerin, Ghrelin and Lipocalin 2 Levels in Diabetic Patients With Periodontitis
This observational cross-sectional study will evaluate salivary apelin, chemerin, ghrelin, and lipocalin-2 levels in individuals with different periodontal and systemic conditions. Participants will be divided into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus.
Clinical periodontal measurements and unstimulated saliva samples will be obtained before periodontal treatment. Salivary biomarker levels will be measured using enzyme-linked immunosorbent assay kits. The study aims to determine whether salivary apelin, chemerin, ghrelin, and lipocalin-2 levels are associated with periodontitis, type 2 diabetes mellitus, and periodontal clinical parameters.
Read the detailed description
This observational cross-sectional study will be conducted at the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University. The study will include individuals who apply to the periodontology clinic for various reasons, meet the eligibility criteria, and agree to participate by signing the informed consent form.
The study population will consist of 88 individuals aged 18-80 years. Participants will be allocated into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus: periodontally healthy and systemically healthy individuals, periodontally healthy individuals with type 2 diabetes mellitus, systemically healthy individuals with periodontitis, and individuals with both periodontitis and type 2 diabetes mellitus. Each group will include 22 participants.
Periodontal status will be determined by a calibrated specialist clinician based on clinical and radiographic examinations according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions. Participants in the periodontitis groups will be required to meet the criteria for generalized Stage II or Stage III periodontitis. Periodontal clinical parameters, including probing depth, clinical attachment loss, bleeding on probing, gingival index, plaque index, gingival recession, tooth mobility, furcation involvement, and keratinized gingival width, will be recorded from six sites per tooth. Sociodemographic data, oral hygiene habits, and body mass index will also be recorded.
Unstimulated saliva samples will be collected before periodontal probing and before periodontal treatment in order to prevent possible contamination of saliva by bleeding during clinical measurements. Participants will be instructed not to brush their teeth and to avoid food, chewing gum, cosmetic products such as lipstick, and medications that may affect salivary measurements for at least one hour before sample collection. Saliva samples will be collected between 8:00 AM and 10:00 AM. After rinsing the mouth with water, saliva will be collected into plastic tubes using a glass funnel within five minutes. The samples will then be centrifuged at 1000 rpm for 10 minutes to remove cellular debris and plaque. The supernatant will be transferred into polypropylene Eppendorf tubes without disturbing the pellet and stored at -20°C until analysis.
On the day of analysis, samples will be thawed at +4°C. Salivary chemerin, ghrelin, apelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions.
The primary objective of the study is to compare salivary apelin, chemerin, ghrelin, and lipocalin-2 levels among individuals with different periodontal and systemic conditions. Secondary objectives include evaluating the relationships between salivary biomarker levels and clinical periodontal parameters and assessing the diagnostic performance of these biomarkers in distinguishing periodontitis from periodontal health.
Statistical analysis will be performed using IBM SPSS Statistics software. Continuous data will be expressed as mean and standard deviation. The normality of data distribution will be assessed using the Kolmogorov-Smirnov test. Between-group comparisons will be performed using appropriate parametric or non-parametric tests according to data distribution. Correlations between clinical and biochemical parameters will be evaluated. Receiver operating characteristic curve analysis will be used to assess the sensitivity and specificity of salivary biomarkers for distinguishing periodontitis from periodontal health. A p-value of less than 0.05 will be considered statistically significant.
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Salivary Biomarker Analysis
- Keywords
- Periodontitis, Type 2 Diabetes Mellitus, Salivary Biomarkers, Apelin, Chemerin
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary Biomarker AnalysisDiagnostic test
Also called ELISA-based salivary biomarker measurement
Unstimulated saliva samples will be collected from participants before periodontal treatment and before periodontal probing. Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions. This procedure is used for biomarker assessment only and does not involve any therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy Systemically Healthy Group | Periodontally healthy individuals without type 2 diabetes mellitus or other systemic diseases. Receives: Diagnostic Test: Salivary Biomarker Analysis | |
| Periodontally Healthy Type 2 Diabetes Group | Periodontally healthy individuals diagnosed with type 2 diabetes mellitus. Receives: Diagnostic Test: Salivary Biomarker Analysis | |
| Periodontitis Systemically Healthy Group | Systemically healthy individuals diagnosed with generalized Stage II or Stage III periodontitis according to the 2017 World Workshop Classification. Receives: Diagnostic Test: Salivary Biomarker Analysis | |
| Periodontitis Type 2 Diabetes Group | Individuals diagnosed with both generalized Stage II or Stage III periodontitis and type 2 diabetes mellitus. Receives: Diagnostic Test: Salivary Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured in unstimulated saliva samples collected before periodontal treatment. Biomarker levels will be analyzed using enzyme-linked immunosorbent assay kits and compared among the four study groups according to periodontal status and the presence or absence of type 2 diabetes mellitus.
Measured: Baseline, before periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Babayigit, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703345
- Sponsor's protocol ID
- NEU-DIS-OB-05
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary Apelin, Chemerin, Ghrelin and Lipocalin 2 Levels in Diabetic Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07703345
- Acronym / sponsor ID
- NEU-DIS-OB-05
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Periodontitis, Type 2 Diabetes Mellitus, Salivary Biomarkers, Apelin, Chemerin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 14 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.
This observational cross-sectional study will evaluate salivary apelin, chemerin, ghrelin, and lipocalin-2 levels in individuals with different periodontal and systemic conditions. Participants will be divided into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus.
Clinical periodontal measurements and unstimulated saliva samples will be obtained before periodontal treatment. Salivary biomarker levels will be measured using enzyme-linked immunosorbent assay kits. The study aims to determine whether salivary apelin, chemerin, ghrelin, and lipocalin-2 levels are associated with periodontitis, type 2 diabetes mellitus, and periodontal clinical parameters.
Detailed description
This observational cross-sectional study will be conducted at the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University. The study will include individuals who apply to the periodontology clinic for various reasons, meet the eligibility criteria, and agree to participate by signing the informed consent form.
The study population will consist of 88 individuals aged 18-80 years. Participants will be allocated into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus: periodontally healthy and systemically healthy individuals, periodontally healthy individuals with type 2 diabetes mellitus, systemically healthy individuals with periodontitis, and individuals with both periodontitis and type 2 diabetes mellitus. Each group will include 22 participants.
Periodontal status will be determined by a calibrated specialist clinician based on clinical and radiographic examinations according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions. Participants in the periodontitis groups will be required to meet the criteria for generalized Stage II or Stage III periodontitis. Periodontal clinical parameters, including probing depth, clinical attachment loss, bleeding on probing, gingival index, plaque index, gingival recession, tooth mobility, furcation involvement, and keratinized gingival width, will be recorded from six sites per tooth. Sociodemographic data, oral hygiene habits, and body mass index will also be recorded.
Unstimulated saliva samples will be collected before periodontal probing and before periodontal treatment in order to prevent possible contamination of saliva by bleeding during clinical measurements. Participants will be instructed not to brush their teeth and to avoid food, chewing gum, cosmetic products such as lipstick, and medications that may affect salivary measurements for at least one hour before sample collection. Saliva samples will be collected between 8:00 AM and 10:00 AM. After rinsing the mouth with water, saliva will be collected into plastic tubes using a glass funnel within five minutes. The samples will then be centrifuged at 1000 rpm for 10 minutes to remove cellular debris and plaque. The supernatant will be transferred into polypropylene Eppendorf tubes without disturbing the pellet and stored at -20°C until analysis.
On the day of analysis, samples will be thawed at +4°C. Salivary chemerin, ghrelin, apelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions.
The primary objective of the study is to compare salivary apelin, chemerin, ghrelin, and lipocalin-2 levels among individuals with different periodontal and systemic conditions. Secondary objectives include evaluating the relationships between salivary biomarker levels and clinical periodontal parameters and assessing the diagnostic performance of these biomarkers in distinguishing periodontitis from periodontal health.
Statistical analysis will be performed using IBM SPSS Statistics software. Continuous data will be expressed as mean and standard deviation. The normality of data distribution will be assessed using the Kolmogorov-Smirnov test. Between-group comparisons will be performed using appropriate parametric or non-parametric tests according to data distribution. Correlations between clinical and biochemical parameters will be evaluated. Receiver operating characteristic curve analysis will be used to assess the sensitivity and specificity of salivary biomarkers for distinguishing periodontitis from periodontal health. A p-value of less than 0.05 will be considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy Systemically Healthy Group | – | Diagnostic Test: Salivary Biomarker AnalysisPeriodontally healthy individuals without type 2 diabetes mellitus or other systemic diseases. |
| Periodontally Healthy Type 2 Diabetes Group | – | Diagnostic Test: Salivary Biomarker AnalysisPeriodontally healthy individuals diagnosed with type 2 diabetes mellitus. |
| Periodontitis Systemically Healthy Group | – | Diagnostic Test: Salivary Biomarker AnalysisSystemically healthy individuals diagnosed with generalized Stage II or Stage III periodontitis according to the 2017 World Workshop Classification. |
| Periodontitis Type 2 Diabetes Group | – | Diagnostic Test: Salivary Biomarker AnalysisIndividuals diagnosed with both generalized Stage II or Stage III periodontitis and type 2 diabetes mellitus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals aged 18 to 80 years who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, meet the eligibility criteria, and agree to participate. Participants will be categorized into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus: periodontally healthy systemically healthy individuals, periodontally healthy individuals with type 2 diabetes mellitus, systemically healthy individuals with periodontitis, and individuals with both periodontitis and type 2 diabetes mellitus.
Key inclusion criteria (5 listed)
- Individuals aged 18 to 80 years. Individuals who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University.
- Individuals who agree to participate in the study and sign the informed consent form.
- Presence of at least 20 teeth. For the periodontally healthy groups: diagnosis of periodontal health based on routine clinical and radiographic examination.
- For the periodontitis groups: diagnosis of generalized Stage II or Stage III periodontitis based on routine clinical and radiographic examination according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.
- For the type 2 diabetes mellitus groups: diagnosis of type 2 diabetes mellitus. For the systemically healthy groups: absence of systemic diseases, including type 2 diabetes mellitus.
Key exclusion criteria (5 listed)
- Periodontal treatment, including scaling and root surface debridement, within the last 6 months.
- Antibiotic use within the last 6 months. Pregnancy or lactation. Presence of autoimmune diseases such as rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behçet disease, or psoriasis.
- Presence of systemic diseases other than type 2 diabetes mellitus in the diabetes groups.
- Presence of systemic diseases such as nephrotic syndrome, chronic renal disease, or cardiovascular disease.
- Smoking 10 or more cigarettes per day.
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 |
|---|---|---|
| Salivary Biomarker AnalysisAlso: ELISA-based salivary biomarker measurementUnstimulated saliva samples will be collected from participants before periodontal treatment and before periodontal probing. Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions. This procedure is used for biomarker assessment only and does not involve any therapeutic intervention. | Diagnostic test | Periodontally Healthy Systemically Healthy Group, Periodontally Healthy Type 2 Diabetes Group, Periodontitis Systemically Healthy Group, Periodontitis Type 2 Diabetes Group |
Primary outcome
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels
Time frame: Baseline, before periodontal treatment
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured in unstimulated saliva samples collected before periodontal treatment. Biomarker levels will be analyzed using enzyme-linked immunosorbent assay kits and compared among the four study groups according to periodontal status and the presence or absence of type 2 diabetes mellitus.
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Type 2 Diabetes Mellitus (T2DM), run by Necmettin Erbakan 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 5 inclusion and 5 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 14 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?
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?
Contact Osman Babayiğit (+90 506 320 84 74, obabayigit@erbakan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels (time frame: Baseline, before periodontal treatment). 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 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.