Clinical trial NCT06803836: Inflammatory Response and Gingival iNOS Levels in Diabetic vs. Non-Diabetic Periodontitis Patients
Official title: Inducible Nitric Oxide Synthase and Proinflammatory Cytokines in Periodontal Disease: Impact of Glycemic Control in T2DM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Type 2 Diabetes
Glycemic Control
Keywords: periodontitis
diabetes
iNOS
glycemic control
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissues
timeFrame: At baseline (single time point)
Secondary outcomes:
measure: Concentration of proinflammatory cytokines (e.g., TNF-α, IL-1β, IFN-γ, and PGE2)
timeFrame: At baseline (single time point)
measure: Correlation between glycemic control (HbA1c levels) and iNOS/cytokine levels
timeFrame: At baseline (single time point)
measure: Periodontal clinical parameters (e.g., probing depth, clinical attachment level)
timeFrame: At baseline (single time point)
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University,
Study officials:
affiliation: Ondokuz Mayıs University, Department of Periodontology
name: Sude YILDIRIM BOLAT, DDS
role: PRINCIPAL_INVESTIGATOR
References: