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Completed

NCT Number: NCT06803836

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Samsun, 55200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissues

    Time frame: At 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 outcomes

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

    Time frame: 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.

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

    Time frame: At 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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