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

December 11, 2024 updated by: AYSE HUMEYRA ORUC, Necmettin Erbakan University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Meram
      • Konya, Meram, Turkey, 42090
        • Necmettin Erbakan University
        • Contact:
        • Contact:
          • Ayşe hümeyra Oruç

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Periodontally healthy, systemically healthy individual
Before starting the treatment of the patients and after each planned treatment, 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 recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment.
Diagnostic test: 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.
Active Comparator: periodontally healthy individuals with type 2 diabetes
Before starting the treatment of the patients and after each planned treatment, 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 recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment.
Diagnostic test: 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.
Active Comparator: Systemically healthy individual with periodontitis
Before starting the treatment of the patients and after each planned treatment, 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 recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment.
Diagnostic test: 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.
Active Comparator: Individual with periodontitis and type 2 diabetes
Before starting the treatment of the patients and after each planned treatment, 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 recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of preoperative periodontal parameters
Time Frame: 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.
before collecting saliva
gingival index measurement
Time Frame: 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.
before collecting saliva
Plaque Index (PI) measurement
Time Frame: 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.
before collecting saliva

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2025

Primary Completion (Estimated)

February 10, 2025

Study Completion (Estimated)

February 20, 2025

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • periodontitisanddiabetes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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