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

Ondokuz Mayıs University

Status: Completed

Conditions: Periodontitis; Glycemic Control; Type 2 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT06803836

DHF.061

Details and patient eligibility

About

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.

Full description

This study is an observational analysis using a cross-sectional time perspective and explores the interplay between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease by evaluating the expression of inducible nitric oxide synthase (iNOS) and proinflammatory mediators (TNF-α, IL-1β, IFN-γ, and PGE2) in gingival tissues. A total of 118 participants were classified into six groups based on their periodontal health and glycemic control status, determined by HbA1c levels.

Gingival biopsies were collected and analyzed using ELISA to measure biomarker levels. The study found significant differences in inflammatory marker concentrations between groups, with poorly controlled T2DM participants showing markedly higher levels of iNOS and cytokines. This aligns with the hypothesis that poor glycemic control amplifies periodontal inflammation and oxidative stress, contributing to tissue destruction.

The findings underline the critical role of glycemic regulation in managing periodontal disease and suggest potential targets, such as iNOS, for therapeutic interventions. This study adheres to ethical standards, including informed consent and approval by the Ondokuz Mayis University Clinical Research Ethics Committee. The results emphasize the bidirectional relationship between diabetes and periodontal health, contributing to a better understanding of the systemic implications of periodontal inflammation.

Enrollment: 118 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

118 participants in 6 patient groups

Systemically Healthy Participants with Periodontitis

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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.