ClinicalTrials.gov record NCT06735313

Changes in Salivary Asprosin, IL-39, IL-40 and IL-1β Levels in Diabetic Patients with Periodontitis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

Evaluation of Salivary Asprosin, IL-39,IL-40 and IL-1β Levels in Diabetic Patients with Periodontitis

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 80 years old
SexAll
LocationTurkey
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This study collects saliva and periodontal exam data from adults aged 18–80 who may have or not have type 2 diabetes and may have or not have periodontitis. It measures salivary asprosin, IL-39, IL-40 and IL-1β and compares levels between four groups (healthy, diabetes only, periodontitis only, both conditions). The study aims to evaluate whether these biomarkers differ by disease status and whether they could help with periodontal diagnosis or monitoring.

What it is studying. The study tests whether levels of asprosin, IL-39, IL-40 and IL-1β in saliva differ between people with and without type 2 diabetes and between people with and without periodontitis, and whether these salivary biomarkers show patterns that might be useful for diagnosing or tracking periodontal disease.

What the researchers hope to learn. To determine whether salivary levels of asprosin, IL-39, IL-40 and IL-1β differ by diabetes and periodontal disease status; to assess correlations with clinical periodontal measures; and to evaluate the biomarkers' diagnostic accuracy (sensitivity/specificity) for distinguishing periodontitis from periodontal health.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The aim of this study is to determine the relationships between asprosin, IL-39, IL-40 and IL-1β in saliva between individuals with and without diabetes and between individuals with periodontitis and healthy individuals and to determine the potential roles of these biomarkers that are multiplied in periodontal disease. The study aims to evaluate whether these biomarkers can be used for periodontal diagnosis or prognosis. The questions answered by the study are as follows: Do asprosin, IL-39, IL-40 and IL-1β biomarker levels differ between individuals with and without diabetes? Do these biomarker levels differ significantly between individuals with periodontitis and individuals who are healthy? Can these biomarkers be used in the early diagnosis or recording the progression of periodontal diseases?

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • Periodontal examination and saliva collection

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • No systemic disease such as nephrotic syndrome, chronic renal disease and cardiovascular disease
  • No dental scaling and root planing treatment in the last 6 months
  • No antibiotic use for any reason
  • Having at least 20 teeth in the mouth
  • Not being pregnant or breastfeeding
  • Inclusion criteria for the periodontally healthy group
  • Having a periodontally healthy diagnosis in routine clinical and radiographic examinations Inclusion criteria for the periodontitis group
  • Diagnosing periodontitis in routine clinical and radiographic examinations

Exclusion criteria

  • Patients with any autoimmune disease (Rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behcet, psoriasis, etc.) - Those who smoke 10 or more cigarettes per day

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

The study is planned to be conducted with 176 individuals with and without periodontal disease between the ages of 18-80 who come to the Department of Periodontics of the Faculty of Dentistry of Necmettin Erbakan University for treatment. Those who sign the 'informed consent form' will be included in the study. In the periodontal examination of each patient who applies to the periodontology clinic, routine radiographic and clinical evaluations are performed, and routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recessions, body/mass index) are taken and archived before the start of the patients' treatments and after each planned treatment. In addition, the sociodemographic data and brushing habits of each patient who will participate in the study are recorded. Saliva samples will also be collected from patients prior to treatment. Individuals will be divided into groups according to their periodontal disease status:

  • 44 periodontally healthy, systemically healthy individuals
  • 44 periodontally healthy, type 2 diabetic individuals
  • 44 periodontitis, systemically healthy individuals
  • 44 periodontitis, type 2 diabetic individuals

A calibrated expert clinician will determine periodontal status according to the criteria of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions based on radiographic and clinical examination. Patients will need to meet the criteria for Stage II and III, generalized, periodontitis to be included in the periodontitis groups. Saliva samples will be collected before periodontal measurements are taken to prevent saliva from bleeding during probing. Participants will be asked not to brush their teeth at least one hour before the sample collection and to avoid any food, sugary gum, cosmetic products such as lipstick, and any medication that will not affect the salivary hormone measurements. A total of 5 2 ml samples, one for each marker, will be collected from each patient between 9:00 and 10:00 in the morning. The samples will be collected in plastic tubes with a glass funnel within five minutes after each participant rinses their mouth with water. The tubes will then be capped and the samples will be centrifuged at 1000 rpm for 10 minutes to remove cellular elements and plaque. The supernatant liquid will be pipetted without touching the sediment formed at the bottom of the tubes, placed in polypropylene Eppendorf tubes, and stored at -20°C until analysis. Analysis of Saliva Samples Samples will be placed at +4°C to be thawed on the day of analysis. ELISA kits will be used to determine Asprosin, IL-39,IL-40, IL-38 and IL-1B levels according to the manufacturer's instructions (Elabscience Biotechnology Co. Ltd). Statistical Analysis Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 23 (IBM Corp., Armonk, NY). Data will be expressed as mean and standard deviation. Data normality will be assessed using the Kolmogorov-Smirnov test. Differences between parameter means in intragroup comparisons of periodontally healthy and periodontitis groups will be assessed using the One-way ANOVA (Bonferroni post-hoc) test. Differences between parameter means between periodontally healthy and periodontitis groups will be assessed using the independent t test. Pearson correlation coefficients will be used to assess correlations between clinical and biochemical parameters. Areas under the curve (AUC) and receiver operating characteristic (ROC) curves will be used to examine the sensitivity and specificity of salivary biomarkers in distinguishing periodontitis from periodontal health. p<0.05 will be considered statistically significant.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join, you will complete a routine periodontal exam and dental X-rays, have basic demographic and oral-hygiene questions recorded, and give saliva samples before treatment. Saliva will be collected in the morning (about 9:00–10:00), after you rinse and avoid brushing, eating, certain products, or medications as requested; multiple small (2 ml) samples will be taken. Periodontal measures (pocket depths, attachment loss, bleeding on probing, plaque and gingival indexes, keratinized tissue, recession, mobility, etc.) and body mass index will be recorded and stored. Samples will be processed and stored for laboratory analysis; no invasive procedures beyond exams, X-rays, and saliva collection are listed.

How the study is structured. Participants are placed into one of four non-randomized groups (healthy, type 2 diabetes only, periodontitis only, both conditions). Each person gives a morning saliva sample before periodontal measurements; a periodontal exam and routine clinical records are taken. This is an interventional diagnostic study with parallel groups and no masking; the main intervention is the diagnostic test of saliva collection and periodontal assessment.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Diabetes Mellitus; Periodontal Disease; Asprosin; Interleukin 1-beta. Does it apply to my diagnosis?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Turkey. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Marfan syndrome

Important dates

Study start
Jan 10, 2025 (estimated)
Primary completion
Feb 10, 2025 (estimated)
Study completion
Feb 20, 2025 (estimated)
Target enrollment
176 participants (estimated)
Last updated on registry
Dec 16, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Necmettin Erbakan University
Principal investigator
AYSE HUMEYRA ORUC, research assistant
Necmettin Erbakan University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
Inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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