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

NCT06735313 | Not Yet Recruiting

• 1 other identifier: periodontitisanddiabetes
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Diabetes Mellitus; Periodontal Disease; Asprosin; Interleukin 1-beta

Outcome Measures

Primary Outcomes (3)

• measurement of preoperative periodontal parameters

  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

  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

  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

Study Arms (4)

Periodontally healthy, systemically healthy individual

OTHER

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

periodontally healthy individuals with type 2 diabetes

ACTIVE COMPARATOR

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

Systemically healthy individual with periodontitis

ACTIVE COMPARATOR

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

Individual with periodontitis and type 2 diabetes

ACTIVE COMPARATOR

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

Interventions

Periodontal examination and saliva collection DIAGNOSTIC_TEST

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

Individual with periodontitis and type 2 diabetes; Periodontally healthy, systemically healthy individual; Systemically healthy individual with periodontitis; periodontally healthy individuals with type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Diagnosing periodontitis in routine clinical and radiographic examinations

You may not qualify if:

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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (2)

• Gul SNS, Eminoglu DO, Laloglu E, Aydin T, Dilsiz A. Salivary and serum asprosin hormone levels in the 2018 EFP/AAP classification of periodontitis stages and body mass index status: a case-control study. Clin Oral Investig. 2024 Jan 13;28(1):91. doi: 10.1007/s00784-024-05494-9.

  PMID: 38217801 BACKGROUND

• Oruc AH, Babayigit O. Salivary asprosin, IL-39, IL-40, and IL-1beta levels in diabetic patients with periodontitis: A cross-sectional analysis. Clin Oral Investig. 2026 Jan 14;30(1):52. doi: 10.1007/s00784-026-06744-8.

  PMID: 41530539 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Periodontal Diseases; Arachnodactyly

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

ayşe hümeyra o oruç

CONTACT

+90 0543 260 94 64; ayse61836@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: January 10, 2025
• Primary Completion: February 10, 2025
• Study Completion: February 20, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

TU (1)