Serum Chromium, Nickel, and Magnesium in Type 2 Diabetic Periodontitis

NCT07327086 | Completed

• 1 other identifier: 2025/172
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a chronic immunoinflammatory disease that has been increasingly associated with systemic conditions, particularly type 2 diabetes mellitus (T2DM). Trace elements such as chromium (Cr), magnesium (Mg), and nickel (Ni) play important roles in metabolic regulation, insulin signaling, inflammatory responses, and tissue integrity. Alterations in the serum levels of these elements have been reported in T2DM; however, their relationship with periodontal status remains poorly understood. This cross-sectional observational study aims to evaluate serum Cr, Mg, and Ni levels in individuals with T2DM and chronic periodontitis and to investigate their potential associations with periodontal clinical parameters.

Conditions

Type 2 Diabetes Mellitus (T2DM); Periodontal Disease

Keywords

Periodontal disease; Trace Elements; Type 2 Diabetes Mellitus; Glycemic Control

Outcome Measures

Primary Outcomes (1)

• Serum levels of chromium, magnesium, and nickel

  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.

  Single time point (cross-sectional assessment)

Secondary Outcomes (3)

• Periodontal clinical parameters

  Single time point

• Association between serum trace element levels and periodontal parameters

  Single time point

• Effect of glycemic control on serum trace element levels

  Single time point

Study Arms (4)

Control group

Systemically and periodontally healthy individuals.

Other: No intervention (Observational study)

Periodontitis group

Systemically healthy individuals with Stage II, Grade B periodontitis.

Other: No intervention (Observational study)

Controlled T2DM with periodontitis group

Individuals with HbA1c \< 7.0 and Stage II, Grade B periodontitis.

Other: No intervention (Observational study)

Uncontrolled T2DM with periodontitis group

Individuals with HbA1c ≥ 7.0 and Stage II, Grade C periodontitis.

Other: No intervention (Observational study)

Interventions

No intervention (Observational study) OTHER

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.

Control group; Controlled T2DM with periodontitis group; Periodontitis group; Uncontrolled T2DM with periodontitis group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult individuals aged 18 years and older who were systemically evaluated at the Department of Endocrinology and Metabolism and subsequently referred for periodontal examination. Participants include systemically and periodontally healthy individuals as well as patients diagnosed with chronic periodontitis, with or without type 2 diabetes mellitus. Eligible participants were allocated into study groups based on periodontal status and glycemic control.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35685677 RESULT

• 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.

  PMID: 40169565 RESULT

Related Links

• Kahramanmaraş Sütçü İmam University Medical Research Ethics Committee

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontal Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• esra bozkurt

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: July 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)