ClinicalTrials.gg
RecruitingNCT07703345Updated Jul 14, 2026

Salivary Apelin, Chemerin, Ghrelin, and Lipocalin-2 Levels in Diabetic Patients With Periodontitis

An observational study in Periodontitis and Type 2 Diabetes Mellitus (T2DM), sponsored by Necmettin Erbakan University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Necmettin Erbakan University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2026; still recruiting 4 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
88
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Periodontitis by Necmettin Erbakan University — 5 open to participants now, 6 under way, none of them phase 3. Periodontitis · Necmettin Erbakan University.

Started
2026
with 1 other
Observational
8 of 12
5 open now
Registered
11th of 12
by date

Among the 12 studies in Periodontitis by Necmettin Erbakan University, this one is one of 2 that started in 2026, is one of 8 observational ones, and was the 11th registered.

Periodontitis

1,232 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

Browse Periodontitis studies →

Open to participants now

5 of the 12 studies in Periodontitis by Necmettin Erbakan University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 158 Periodontitis studies recruiting now, 78 (49%) set no upper age limit and 60 (38%) stop at 75 or younger; 12 take children under 18; 76 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Periodontitis by Necmettin Erbakan University, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Periodontitis
  • Type 2 Diabetes Mellitus (T2DM)

Keywords

  • Periodontitis
  • Type 2 Diabetes Mellitus
  • Salivary Biomarkers
  • Apelin
  • Chemerin
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
88 participants (estimated)
Patient registry
No

Groups and cohorts

  • Periodontally Healthy Systemically Healthy Group

    Periodontally healthy individuals without type 2 diabetes mellitus or other systemic diseases.

    Diagnostic Test: Salivary Biomarker Analysis

  • Periodontally Healthy Type 2 Diabetes Group

    Periodontally healthy individuals diagnosed with type 2 diabetes mellitus.

    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.

    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.

    Diagnostic Test: Salivary Biomarker Analysis

Interventions

  • Diagnostic testSalivary Biomarker Analysis

    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.

    Also known as: ELISA-based salivary biomarker measurement

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, before periodontal treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Aug 2026, 1 month after the start.

Of 85 non-industry observational studies under Periodontitis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 1 month is below that.

Counting every sponsor, half of 86 studies reached it within 13 months; a quarter within 7 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2026
First posted
Jul 14, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Aug 1, 2026
CompletionEst.
Aug 1, 2026
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07703345
Responsible party
Osman Babayigit (Principal Investigator, Necmettin Erbakan University) — Principal investigator
First posted
Jul 14, 2026
Start date
Jul 1, 2026
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jul 14, 2026

Study contacts

Osman Babayiğit
Contact
obabayigit@erbakan.edu.tr
+90 506 320 84 74

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion