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

Inducible Nitric Oxide Synthase and Proinflammatory Cytokines in Periodontal Disease: Impact of Glycemic Control in T2DM

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06803836
Enrollment
118
Registered
2025-01-31
Start date
2020-01-10
Completion date
2022-03-10
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycemic Control, Periodontitis, Type 2 Diabetes

Keywords

periodontitis, diabetes, iNOS, glycemic control

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.

Detailed 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.

Interventions

None listed

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissuesAt baseline (single time point)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.

Secondary

MeasureTime frameDescription
Concentration of proinflammatory cytokines (e.g., TNF-α, IL-1β, IFN-γ, and PGE2)At baseline (single time point)The levels of cytokines will be analyzed in gingival tissue samples to investigate their relationship with iNOS expression and differences between study groups.
Correlation between glycemic control (HbA1c levels) and iNOS/cytokine levelsAt baseline (single time point)The study will examine the relationship between glycemic control (as determined by HbA1c levels) and biomarkers to evaluate the impact of diabetes control on periodontal inflammation.
Periodontal clinical parameters (e.g., probing depth, clinical attachment level)At baseline (single time point)Clinical periodontal measurements, such as probing depth (PD) and clinical attachment level (CAL), will be recorded to assess the severity of periodontal disease in each group.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026