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

NCT06735313 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-01-10
Last updated
2024-12-16

Condition(s) studied

Diabetes MellitusPeriodontal DiseaseAsprosinInterleukin 1-beta

Investigational drug(s) / intervention(s)

Periodontal examination and saliva collection

Periodontal examination and saliva collection: Before the periodontal examination, saliva samples are collected from each patient participating in the study and periodontal measurements are made.

Study summary

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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • measurement of preoperative periodontal parameters — before collecting saliva
    To determine the baseline condition, preoperative measurement of periodontal parameters (amount of keratinized tissue, papilla height, papilla width, probing pocket depth, amount of recession, tissue thickness) will be recorded in millimeters using a periodontal probe.
  • gingival index measurement — before collecting saliva
    The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding). Unit of Measurement: 0-3 scale.
  • Plaque Index (PI) measurement — before collecting saliva
    The degree of plaque accumulation on the tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The assessment will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This measurement will be used to objectively determine the degree of plaque formation.Unit of Measurement: 0-3 scale.

Trial sites (1)

FacilityCityRegionStatus
Necmettin Erbakan University Konya Meram
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06735313 on ClinicalTrials.gov ↗ ← All trials in Turkey