Inducible Nitric Oxide Synthase and Proinflammatory Cytokines in Periodontal Disease: Impact of Glycemic Control in T2DM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissues
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissues
时间窗: 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.
次要结局
- 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))
研究者
Sude Yildirim
Principal Investigator, Research Assistant
Ondokuz Mayıs University