- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327086
Serum Chromium, Nickel, and Magnesium in Type 2 Diabetic Periodontitis
Evaluation of Serum Chromium, Nickel, and Magnesium Levels in Patients With Type 2 Diabetes Mellitus and Periodontitis: A Cross-Sectional Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Detailed Description
Periodontal diseases are chronic immunoinflammatory conditions initiated by the interaction between the microbial dental plaque biofilm and the host immune response, leading to progressive destruction of the alveolar bone and connective tissues. Although traditionally considered localized oral infections, increasing evidence indicates that periodontitis has significant systemic implications. A well-established bidirectional relationship exists between periodontitis and type 2 diabetes mellitus (T2DM), with periodontitis being recognized as the sixth complication of diabetes. Both conditions are characterized by elevated proinflammatory cytokines and mediators, which may mutually exacerbate disease severity and progression.
Chromium (Cr) is an essential trace element involved in carbohydrate and lipid metabolism and plays a key role in insulin signaling by enhancing insulin receptor activity through its interaction with chromodulin. Chromium deficiency has been proposed as a potential risk factor for the development of diabetes, and chromium supplementation has been reported to improve glycemic control in some individuals with T2DM. Although limited studies suggest alterations in salivary chromium levels in patients with chronic periodontitis, possibly due to periodontal tissue breakdown or metal release from restorative materials, the association between periodontal disease and serum chromium levels has not been directly investigated to date.
Magnesium (Mg) is a vital mineral acting as a cofactor for more than 300 enzymatic reactions and is essential for energy metabolism, oxidative phosphorylation, and membrane integrity. Reduced serum magnesium levels are commonly observed in individuals with T2DM, and magnesium deficiency has been associated with impaired glucose-insulin metabolism and enhanced inflammatory responses. Experimental and clinical studies suggest that magnesium deficiency may aggravate periodontal inflammation and negatively affect periodontal tissue healing; however, studies evaluating magnesium status in individuals with concomitant T2DM and chronic periodontitis are limited.
Nickel (Ni) is a widely distributed environmental heavy metal, and human exposure occurs through air, water, food, tobacco products, dental materials, and metal alloys. Evidence regarding the association between nickel exposure and diabetes is inconsistent, with some studies reporting no association and others suggesting an increased risk of diabetes with higher nickel exposure. To date, no studies have directly evaluated the relationship between periodontal disease and serum nickel levels.
Given the complex interactions among trace elements in metabolic and inflammatory pathways, the simultaneous evaluation of serum chromium, magnesium, and nickel levels may provide valuable insights into the pathophysiology of T2DM and chronic periodontitis. However, current literature lacks studies assessing these three elements together in individuals with T2DM and chronic periodontitis.
This cross-sectional observational study was conducted in accordance with the Declaration of Helsinki and approved by the Kahramanmaraş Sütçü İmam University Medical Faculty Ethics Committee. Adult participants were recruited from individuals undergoing systemic evaluation at the Department of Endocrinology and Metabolism and subsequently referred for periodontal examination. Eligible participants were allocated into four groups based on systemic and periodontal status: periodontally and systemically healthy controls, systemically healthy individuals with chronic periodontitis, individuals with controlled T2DM and chronic periodontitis, and individuals with uncontrolled T2DM and chronic periodontitis.
Comprehensive periodontal examinations were performed by a calibrated examiner using standard clinical indices, including plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level. Periodontal diagnoses were established according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions. Fasting venous blood samples were collected, and serum chromium, magnesium, and nickel levels were analyzed using atomic absorption spectrometry.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kahramanmaraş, Turkey (Türkiye)
- Kahramanmaraş Sütçü İmam University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged ≥18 years
- Having at least 20 natural teeth, excluding third molars
- Diagnosed with type 2 diabetes mellitus or systemically healthy, according to group allocation
- Willingness to participate in the study and provision of written informed consent
Exclusion Criteria:
- Presence of systemic diseases other than type 2 diabetes mellitus (e.g., renal or hepatic failure, cardiovascular disease, organ transplantation, or current or previous cancer treatment)
- Use of antibiotics, non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressive drugs, calcium channel blockers, beta blockers, oral contraceptives, or anticoagulants within the last 3 months
- History of non-surgical periodontal treatment within the last 6 months or periodontal surgery within the last 12 months
- Pregnancy or lactation
- Body mass index (BMI) ≥ 30 kg/m²
- Current smoking or alcohol consumption
- Use of vitamin, mineral, or antioxidant supplements within the last 3 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Control group
Systemically and periodontally healthy individuals.
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Participants were not assigned to any therapeutic or preventive intervention.
The study involved periodontal examination and blood sample collection for serum trace element analysis only.
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Periodontitis group
Systemically healthy individuals with Stage II, Grade B periodontitis.
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Participants were not assigned to any therapeutic or preventive intervention.
The study involved periodontal examination and blood sample collection for serum trace element analysis only.
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Controlled T2DM with periodontitis group
Individuals with HbA1c < 7.0 and Stage II, Grade B periodontitis.
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Participants were not assigned to any therapeutic or preventive intervention.
The study involved periodontal examination and blood sample collection for serum trace element analysis only.
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Uncontrolled T2DM with periodontitis group
Individuals with HbA1c ≥ 7.0 and Stage II, Grade C periodontitis.
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Participants were not assigned to any therapeutic or preventive intervention.
The study involved periodontal examination and blood sample collection for serum trace element analysis only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Serum levels of chromium, magnesium, and nickel
Time Frame: Single time point (cross-sectional assessment)
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The primary outcome is the assessment of fasting serum chromium, magnesium, and nickel concentrations measured using atomic absorption spectrometry in individuals with type 2 diabetes mellitus with and without chronic periodontitis, and systemically healthy controls.
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Single time point (cross-sectional assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Periodontal clinical parameters
Time Frame: Single time point
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Plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level assessed during periodontal examination.
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Single time point
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Association between serum trace element levels and periodontal parameters
Time Frame: Single time point
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Evaluation of correlations between serum chromium, magnesium, and nickel levels and periodontal clinical measurements.
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Single time point
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Effect of glycemic control on serum trace element levels
Time Frame: Single time point
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Comparison of serum chromium, magnesium, and nickel levels between controlled (HbA1c < 7.0) and uncontrolled (HbA1c ≥ 7.0) type 2 diabetes mellitus groups.
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Single time point
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Collaborators and Investigators
Investigators
- Principal Investigator: esra bozkurt, Kahramanmaraş Sütçü İmam University
Publications and helpful links
General Publications
- Titcomb TJ, Liu B, Lehmler HJ, Snetselaar LG, Bao W. Environmental Nickel Exposure and Diabetes in a Nationally Representative Sample of US Adults. Expo Health. 2021 Dec;13(4):697-704. doi: 10.1007/s12403-021-00413-9. Epub 2021 Sep 29.
- Toaima DN, Abdel-Maksoud KS, Atef HM, Salah NY. Magnesium, fibrinolysis and clotting interplay among children and adolescents with type 1 diabetes mellitus; potential mediators of diabetic microangiopathy. Nutr Diabetes. 2025 Apr 1;15(1):13. doi: 10.1038/s41387-025-00368-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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