Type 2 Diabetes Mellitus (T2DM)NCT07327086
Serum Chromium, Nickel, and Magnesium in Type 2 Diabetic Periodontitis
An observational study of Type 2 Diabetes Mellitus (T2DM) and Periodontal Disease, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Periodontal Disease
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş
About this study
Official title: Evaluation of Serum Chromium, Nickel, and Magnesium Levels in Patients With Type 2 Diabetes Mellitus and Periodontitis: A Cross-Sectional Study
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.
Read the 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.
- Being tested
- No intervention (Observational study)
- Keywords
- Periodontal disease, Trace Elements, Type 2 Diabetes Mellitus, Glycemic Control
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Systemically and periodontally healthy individuals. Receives: Other: No intervention (Observational study) | |
| Periodontitis group | Systemically healthy individuals with Stage II, Grade B periodontitis. Receives: Other: No intervention (Observational study) | |
| Controlled T2DM with periodontitis group | Individuals with HbA1c < 7.0 and Stage II, Grade B periodontitis. Receives: Other: No intervention (Observational study) | |
| Uncontrolled T2DM with periodontitis group | Individuals with HbA1c ≥ 7.0 and Stage II, Grade C periodontitis. Receives: Other: No intervention (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single time point (cross-sectional assessment)
Secondary outcomes (3)
Periodontal clinical parameters
Plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level assessed during periodontal examination.
Measured: Single time point
Association between serum trace element levels and periodontal parameters
Evaluation of correlations between serum chromium, magnesium, and nickel levels and periodontal clinical measurements.
Measured: Single time point
Effect of glycemic control on serum trace element levels
Comparison of serum chromium, magnesium, and nickel levels between controlled (HbA1c < 7.0) and uncontrolled (HbA1c ≥ 7.0) type 2 diabetes mellitus groups.
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jul 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Bozkurt, Kahramanmaras Sutcu Imam University
- Investigators
- esra bozkurt, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327086
- Sponsor's protocol ID
- 2025/172
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers, as there is no predefined data-sharing plan in the study protocol or informed consent, and all data will be used solely for the purposes of the present research in accordance with ethical approval and data protection regulations.
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.
PubMed 35685677Toaima 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.
PubMed 40169565Bozkurt E, Ozdemir EC, Gul K, Kilinc M, Gulmez R. Evaluation of serum chromium, nickel, and magnesium levels in patients with type 2 diabetes mellitus and periodontitis: A cross-sectional study. Clin Oral Investig. 2026 Jul 27;30(8):361. doi: 10.1007/s00784-026-07049-6.
PubMed 42507181
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Chromium, Nickel, and Magnesium Levels in Patients With Type 2 Diabetes Mellitus and Periodontitis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07327086
- Acronym / sponsor ID
- 2025/172
- Keywords
- Periodontal disease, Trace Elements, Type 2 Diabetes Mellitus, Glycemic Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: No intervention (Observational study)Systemically and periodontally healthy individuals. |
| Periodontitis group | – | Other: No intervention (Observational study)Systemically healthy individuals with Stage II, Grade B periodontitis. |
| Controlled T2DM with periodontitis group | – | Other: No intervention (Observational study)Individuals with HbA1c < 7.0 and Stage II, Grade B periodontitis. |
| Uncontrolled T2DM with periodontitis group | – | Other: No intervention (Observational study)Individuals with HbA1c ≥ 7.0 and Stage II, Grade C periodontitis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (Observational study)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. | Other | Control group, Controlled T2DM with periodontitis group, Periodontitis group, Uncontrolled T2DM with periodontitis group |
Primary outcome
Serum levels of chromium, magnesium, and nickel
Time frame: Single time point (cross-sectional assessment)
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.
3 secondary outcomes
Periodontal clinical parameters
Time frame: Single time point
Association between serum trace element levels and periodontal parameters
Time frame: Single time point
Effect of glycemic control on serum trace element levels
Time frame: Single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Results publication: PubMed 35685677Titcomb 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.
- Results publication: PubMed 40169565Toaima 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.
- Derived from this study: PubMed 42507181Bozkurt E, Ozdemir EC, Gul K, Kilinc M, Gulmez R. Evaluation of serum chromium, nickel, and magnesium levels in patients with type 2 diabetes mellitus and periodontitis: A cross-sectional study. Clin Oral Investig. 2026 Jul 27;30(8):361. doi: 10.1007/s00784-026-07049-6.
- Kahramanmaraş Sütçü İmam University Medical Research Ethics CommitteeLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers, as there is no predefined data-sharing plan in the study protocol or informed consent, and all data will be used solely for the purposes of the present research in accordance with ethical approval and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
esra bozkurt principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Periodontal Disease, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of chromium, magnesium, and nickel (time frame: Single time point (cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07327086, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.