Chemerin, Fetuin-A, IL-34 and IL-13 Levels in Diabetic Periodontitis Patients

NCT06135532 | Completed

• 1 other identifier: SAG-A-080519-0172
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary chemerin, fetuin-A, IL-34 and IL-13 levels in periodontitis with and without diabetes mellitus (DM) type 2. 22 non-periodontitis, 22 non-periodontitis with DM, 22 Stage III/IV Grade C periodontitis, 22 tage III/IV Grade C periodontitis with well-controlled DM and 22 tage III/IV Grade C periodontitis with poorly-controlled DM patients were enrolled. At baseline, serum and saliva samples were collected, and the whole mouth clinical periodontal parameters were recorded from all subjects. Periodontitis patients received non-surgical periodontal therapy. Clinical parameters were re-measured, and samples were re-collected 1 and 3 months after therapy from periodontitis patients. Serum and salivary protein levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

Conditions

Periodontitis; Diabetes Mellitus, Type 2

Keywords

periodontitis; Diabetes mellitus; periodontal therapy

Outcome Measures

Primary Outcomes (4)

• salivary chemerin level (ng/ml)

  change in salivary chemerin levels

  baseline to 3 months after non-surgical

• salivary fetuin-A level (ng/ml)

  change in salivary fetuin-A levels

  baseline to 3 months after non-surgical

• salivary IL-34 level (pg/ml)

  change in salivary IL-34 levels

  baseline to 3 months after non-surgical

• salivary IL-13 level (pg/ml)

  change in salivary IL-13 levels

  baseline to 3 months after non-surgical

Secondary Outcomes (4)

• serum chemerin level (ng/ml)

  baseline to 3 months after non-surgical

• serum fetuin-A level (ng/ml)

  baseline to 3 months after non-surgical

• serum IL-34 level (pg/ml)

  baseline to 3 months after non-surgical

• serum IL-13 level (pg/ml)

  baseline to 3 months after non-surgical

Study Arms (5)

Non-Periodontitis

NO INTERVENTION

Only received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes.

Non-Peridontitis with T2DM

NO INTERVENTION

Only received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes.

Periodontitis

ACTIVE COMPARATOR

The patients received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes. The patients underwent quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment was completed in a total of 4 sessions in four weeks.

Procedure: Non-Surgical Periodontal Treatment

Periodontitis with well-controlled T2DM

ACTIVE COMPARATOR

The patients received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes. The patients underwent quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment was completed in a total of 4 sessions in four weeks.

Procedure: Non-Surgical Periodontal Treatment

Periodontitis with poorly-controlled T2DM

ACTIVE COMPARATOR

The patients received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes. The patients underwent quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment was completed in a total of 4 sessions in four weeks.

Procedure: Non-Surgical Periodontal Treatment

Interventions

Non-Surgical Periodontal Treatment PROCEDURE

Nonsurgical periodontal therapy primarily aims to control microbial periodontal infection by removing bacterial biofilm, calculus, and toxins from periodontally involved root surfaces. Performing a thorough periodontal debridement under local anesthesia will stop disease progression and improve active disease's clinical signs and symptoms.

Periodontitis; Periodontitis with poorly-controlled T2DM; Periodontitis with well-controlled T2DM

Eligibility Criteria

• Age: 23 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-smoker individuals
• having ≥20 teeth present (except third molars)
• individuals with non-periodontitis (healthy or gingivitis) and stage III grade C periodontitis diagnoses
• diagnosed at least one year ago as having T2DM and treated with oral anti-diabetics and/or insulin, no major diabetic complications (retinopathy, nephropathy, neuropathy)

You may not qualify if:

• having any diagnosed medical disorders other than diabetes mellitus, such as cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
• usage of antibiotics, non-steroidal anti-inflammatory drugs, and immunosuppressive agents within the past 6 months.
• periodontal treatment within the preceding 6 months.
• pregnant/ lactating/ postmenopausal females.
• current orthodontic treatment.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (1)

• Gorgulu NG, Gungormek HS, Kalkan Y, Dogan B. Evaluation of chemerin, fetuin-A, interleukin-34, and interleukin-13 levels following periodontal treatment in diabetes mellitus. Clin Oral Investig. 2025 Sep 11;29(10):448. doi: 10.1007/s00784-025-06539-3.

  PMID: 40932532 DERIVED

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hatice Selin Yıldırım, PhD

  Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: October 1, 2018
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2020
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)