Inflammatory Response and Gingival iNOS Levels in Diabetic vs. Non-Diabetic Periodontitis Patients

NCT06803836 | Completed

• 1 other identifier: DHF.061
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the relationship between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease. Researchers analyzed the levels of inducible nitric oxide synthase (iNOS) and proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interferon-gamma (IFN-γ), in 118 participants. The participants were categorized based on their periodontal and diabetes control status.

Conditions

Periodontitis; Type 2 Diabetes; Glycemic Control

Keywords

periodontitis; diabetes; iNOS; glycemic control

Outcome Measures

Primary Outcomes (1)

• Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissues

  iNOS levels will be measured in gingival tissue biopsies collected from all participants using ELISA. The aim is to assess the differences in iNOS expression across groups with varying periodontal and glycemic control statuses.

  At baseline (single time point)

Secondary Outcomes (3)

• Concentration of proinflammatory cytokines (e.g., TNF-α, IL-1β, IFN-γ, and PGE2)

  At baseline (single time point)

• Correlation between glycemic control (HbA1c levels) and iNOS/cytokine levels

  At baseline (single time point)

• Periodontal clinical parameters (e.g., probing depth, clinical attachment level)

  At baseline (single time point)

Study Arms (6)

Systemically Healthy Participants with Periodontitis

This group includes participants with periodontitis but without any systemic conditions such as diabetes. Periodontitis diagnosis is based on clinical attachment loss (CAL) and probing depth (PD) criteria.

Systemically and Periodontally Healthy Participants

This group includes systemically and periodontally healthy participants. They serve as a control group to compare inflammatory biomarker levels under healthy conditions.

Uncontrolled T2DM Participants with Periodontitis

Participants in this group have Type 2 diabetes mellitus (T2DM) with HbA1c levels \>7 (uncontrolled diabetes) and periodontitis. Periodontal and systemic conditions were assessed.

Controlled T2DM Participants with Periodontitis

This group includes participants with T2DM whose diabetes is well-controlled (HbA1c ≤7) and who have periodontitis. Clinical evaluations were performed.

Controlled T2DM Periodontally Healthy Participants

Participants in this group have controlled T2DM (HbA1c ≤7) but no periodontal disease. They serve as a control group for comparing biomarker levels under controlled glycemic conditions.

Uncontrolled T2DM Periodontally Healthy Participants

This group includes participants with uncontrolled T2DM (HbA1c \>7) but no periodontal disease. Biomarker levels were measured to evaluate the effects of poor glycemic control on otherwise healthy periodontal tissues.

Eligibility Criteria

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

Study Population

Study participants will be selected from individuals seeking dental care at the Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University, Samsun, Turkey. The population includes adults with varying systemic and periodontal health statuses, such as individuals with Type 2 diabetes mellitus (T2DM) and/or periodontitis. Participants represent a diverse clinical population from the surrounding region and are recruited based on their suitability for the study's objectives.

You may qualify if:

• Participants must be between 18 and 65 years of age (according to the World Health Organization definition of young and adult individuals).
• Diagnosed with periodontitis (Stage 2, 3, or 4) based on the 2017 Classification of Periodontal Diseases and Conditions.
• Diabetes control status determined by HbA1c levels: controlled diabetes: HbA1c ≤ 7, uncontrolled diabetes: HbA1c \> 7
• Must volunteer and sign an informed consent form for clinical evaluations and collection of tissue samples.

You may not qualify if:

• History of smoking.
• Presence of systemic or local diseases affecting the immune system (e.g., autoimmune disorders, HIV, hepatitis).
• Pregnant or breastfeeding individuals.
• History of antibiotic use or periodontal treatment within the last 3-6 months.
• History of immunosuppressive therapy or chemotherapy.
• Requirement for antibiotic prophylaxis.
• Severe systemic illnesses unrelated to diabetes (e.g., cancer, cardiovascular diseases).

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University,

Samsun, 55200, Turkey (Türkiye)

Location

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

• Sude YILDIRIM BOLAT, DDS

  Ondokuz Mayıs University, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: January 10, 2020
• Primary Completion: January 10, 2022
• Study Completion: March 10, 2022
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)