PeriodontitisNCT07905209
Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis
An observational study of Periodontitis and Type 2 Diabetes Mellitus (DM), run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a chronic inflammatory disease that affects the tissues supporting the teeth and can lead to progressive tissue destruction. Type 2 diabetes mellitus is a metabolic disease characterized by persistently elevated blood glucose levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Type 2 Diabetes Mellitus (DM)
- What is being tested?
- MTHFR and DNMT3B Genetic Polymorphism Analysis
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2026to 2 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of 200 adults recruited from the Department of Periodontology, Faculty of Dentistry, Akdeniz University, Antalya, Türkiye. Participants are divided into four groups of 50 individuals each: systemically and periodontally healthy controls, individuals with type 2 diabetes mellitus without periodontitis, individuals with periodontitis without type 2 diabetes mellitus, and individuals with both type 2 diabetes mellitus and periodontitis. Periodontal clinical parameters are recorded, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms.
Who may be able to join
- Being a non-smoker.
- Having received no periodontal treatment within the last 6 months.
- Having no systemic disease known to affect periodontal health other than diabetes mellitus (e.g., hypertension, cardiovascular diseases).
- Having no infectious diseases such as tuberculosis, hepatitis, or AIDS.
- Being 18 years of age or older.
- Not being pregnant (for female participants).
Who cannot join
- Current smokers.
- Individuals who have received periodontal treatment within the last 6 months.
- Individuals with systemic diseases known to affect periodontal health other than diabetes mellitus (e.g., hypertension, cardiovascular diseases).
- Individuals with infectious diseases such as tuberculosis, hepatitis, or AIDS.
- Individuals under 18 years of age.
- Pregnant women.
- Individuals who refuse to participate in the study or do not provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University, Faculty of Dentistry, Department of Periodontology
Antalya, Antalya, 07058
About this study
Periodontitis is a chronic inflammatory disease that affects the tissues supporting the teeth and can lead to progressive tissue destruction. Type 2 diabetes mellitus is a metabolic disease characterized by persistently elevated blood glucose levels. These two conditions are closely related, and genetic factors may influence their development and severity.
This observational study aims to evaluate the distribution of methylenetetrahydrofolate reductase (MTHFR) and DNA methyltransferase 3B (DNMT3B) gene polymorphisms in healthy individuals, individuals with periodontitis, individuals with type 2 diabetes mellitus, and individuals with both conditions. The study also aims to investigate the associations between these genetic variations and periodontal clinical parameters.
Read more
The study includes 200 participants divided into four groups of 50 individuals each: healthy individuals, individuals with type 2 diabetes without periodontitis, individuals with periodontitis without type 2 diabetes, and individuals with both type 2 diabetes and periodontitis.
Periodontal examinations include the assessment of plaque index, gingival index, probing pocket depth, clinical attachment loss, and gingival recession. Venous blood samples are collected for molecular analysis of MTHFR and DNMT3B gene polymorphisms.
The findings may contribute to a better understanding of the potential role of genetic factors in periodontal disease and its relationship with type 2 diabetes mellitus.
Read the detailed description
Periodontitis is a multifactorial chronic inflammatory disease characterized by inflammation and progressive destruction of the tooth-supporting tissues. Although microbial dental plaque is the primary etiological factor, the host immune response, environmental factors, and genetic susceptibility play important roles in the initiation and progression of the disease. Variations in disease severity among individuals highlight the potential contribution of genetic factors to periodontal disease pathogenesis.
Diabetes mellitus is a metabolic disease characterized by chronic hyperglycemia. It can impair immune system functions, enhance inflammatory responses, and accelerate periodontal tissue destruction. A bidirectional relationship between periodontitis and diabetes mellitus has been established. While diabetes increases the prevalence and severity of periodontal disease, periodontitis may negatively affect glycemic control by contributing to systemic inflammation. Therefore, both diseases may influence each other through shared pathophysiological mechanisms.
In recent years, increasing attention has been given to the role of genetic and epigenetic mechanisms in the pathogenesis of these diseases. The methylenetetrahydrofolate reductase (MTHFR) gene encodes an enzyme involved in folate metabolism and plays a critical role in the regulation of homocysteine metabolism. Commonly investigated MTHFR polymorphisms, including C677T (rs1801133) and A1298C (rs1801131), may reduce enzyme activity and contribute to elevated homocysteine levels, which have been associated with inflammation, oxidative stress, and vascular dysfunction.
The DNA methyltransferase 3B (DNMT3B) gene encodes an important epigenetic regulator involved in the regulation of gene expression through DNA methylation. The -149 C>T (rs2424913) polymorphism, located in the promoter region of the DNMT3B gene, may influence gene expression and modulate inflammatory responses. Through these mechanisms, this genetic variation may contribute to the pathogenesis of periodontal disease and diabetes mellitus.
Based on these findings, MTHFR and DNMT3B gene polymorphisms may play a role in the development and progression of periodontitis and diabetes mellitus. However, studies evaluating these genetic variations together with periodontal clinical parameters remain limited.
The primary aim of this study is to investigate the distribution of MTHFR and DNMT3B gene polymorphisms among healthy individuals, individuals with periodontitis alone, individuals with type 2 diabetes mellitus alone, and individuals with both type 2 diabetes mellitus and periodontitis. Additionally, the study aims to evaluate the associations between these genetic variations and periodontal clinical parameters, including plaque index, gingival index, probing pocket depth, clinical attachment loss, and gingival recession.
This observational study is conducted at the Department of Periodontology, Faculty of Dentistry, Akdeniz University, Antalya, Türkiye. A total of 200 participants are included in four groups, each consisting of 50 individuals:
- Periodontally healthy individuals without type 2 diabetes mellitus (n=50).
- Individuals with type 2 diabetes mellitus without periodontitis (n=50).
- Individuals with periodontitis without type 2 diabetes mellitus (n=50).
- Individuals with both type 2 diabetes mellitus and periodontitis (n=50).
All participants undergo a comprehensive periodontal clinical examination. Periodontal parameters include the plaque index to assess dental plaque accumulation, gingival index to evaluate gingival inflammation, probing pocket depth to determine the depth of periodontal pockets, clinical attachment loss to assess periodontal tissue destruction, and gingival recession to determine the extent of gingival tissue recession.
Venous blood samples are collected from participants, and molecular methods are used to analyze MTHFR and DNMT3B gene polymorphisms. The collected clinical and genetic data will be statistically evaluated to investigate the associations between genetic polymorphisms and periodontal clinical parameters across the four study groups.
The results of this study may provide further insight into the potential contribution of genetic and epigenetic factors to periodontal disease and the relationship between periodontitis and type 2 diabetes mellitus.
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus (DM)
- Being tested
- MTHFR and DNMT3B Genetic Polymorphism Analysis
- Keywords
- MTHFR Gene Polymorphism, DNMT3B Gene Polymorphism, Genetic Suspectibility, Periodontal Clinical Parameters, DNA Methylation, Type 2 Diabetes Mellitus, Periodontitis
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTHFR and DNMT3B Genetic Polymorphism AnalysisDiagnostic test
Venous blood samples are collected from participants in all four study groups. DNA extracted from these samples is analyzed to identify MTHFR (C677T and A1298C) and DNMT3B (-149 C>T) gene polymorphisms. The genetic findings will be evaluated in relation to periodontal clinical parameters and the presence of type 2 diabetes mellitus and periodontitis. No therapeutic intervention is administered as part of this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | This group consists of 50 systemically and periodontally healthy individuals without type 2 diabetes mellitus or periodontitis. Periodontal clinical parameters are evaluated, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms. Receives: Diagnostic Test: MTHFR and DNMT3B Genetic Polymorphism Analysis | |
| Type 2 Diabetes Mellitus Group | This group consists of 50 individuals diagnosed with type 2 diabetes mellitus without periodontitis. Periodontal clinical parameters are evaluated, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms. Receives: Diagnostic Test: MTHFR and DNMT3B Genetic Polymorphism Analysis | |
| Periodontitis Group | This group consists of 50 individuals diagnosed with periodontitis without type 2 diabetes mellitus. Periodontal clinical parameters are evaluated, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms. Receives: Diagnostic Test: MTHFR and DNMT3B Genetic Polymorphism Analysis | |
| Type 2 Diabetes and Periodontitis Group | This group consists of 50 individuals diagnosed with both type 2 diabetes mellitus and periodontitis. Periodontal clinical parameters are evaluated, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms. Receives: Diagnostic Test: MTHFR and DNMT3B Genetic Polymorphism Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTHFR C677T (rs1801133) Genotype Distribution
The distribution of MTHFR C677T (rs1801133) genotypes (CC, CT, and TT) will be determined using DNA extracted from venous blood samples. Genotype frequencies will be compared among the four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both conditions.
Measured: At baseline (single blood sample collection)
MTHFR A1298C (rs1801131) Genotype Distribution
The distribution of MTHFR A1298C (rs1801131) genotypes (AA, AC, and CC) will be determined using DNA extracted from venous blood samples. Genotype frequencies will be compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
Measured: At baseline (single blood sample collection)
DNMT3B -149C>T (rs2424913) Genotype Distribution
The distribution of DNMT3B -149C>T (rs2424913) genotypes (CC, CT, and TT) will be determined using DNA extracted from venous blood samples. Genotype frequencies will be compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
Measured: At baseline (single blood sample collection)
Secondary outcomes (5)
Plaque Index (PI) Score
Plaque accumulation will be assessed using the Plaque Index (PI). The PI score will be recorded during the baseline periodontal examination and compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
Measured: At baseline (single periodontal examination)
Gingival Index (GI) Score
Gingival inflammation will be assessed using the Gingival Index (GI). The GI score will be recorded during the baseline periodontal examination and compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
Measured: At baseline (single periodontal examination)
Probing Pocket Depth (PPD)
Probing Pocket Depth (PPD) will be measured in millimeters (mm) using a periodontal probe during the baseline periodontal examination. PPD values will be compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
Measured: At baseline (single periodontal examination)
Clinical Attachment Loss (CAL)
Clinical Attachment Loss (CAL) will be measured in millimeters (mm) as the distance from the cementoenamel junction to the base of the periodontal pocket using a periodontal probe. CAL values will be recorded during the baseline periodontal examination and compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
Measured: At baseline (single periodontal examination)
Gingival Recession (GR)
Gingival Recession (GR) will be measured in millimeters (mm) as the distance from the cementoenamel junction to the gingival margin using a periodontal probe. GR values will be recorded during the baseline periodontal examination and compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
Measured: At baseline (single periodontal examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start2 Apr 2026
- Primary completion2 Aug 2026
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nezahat Arzu Kayar, DDS, PhD, Principal investigator, Akdeniz University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905209
- Sponsor's protocol ID
- TBAEK-336
- Other IDs
- TDH-2026-7203
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers due to participant confidentiality and the sensitive nature of genetic and clinical health information. The collected data will be used exclusively for the purposes of the approved research study. Study findings will be reported in aggregate form without disclosing individual participant information.
Publications
Kocaman G, Orbak R. Investigation of the Methylenetetrahydrofolate Reductase Gene C677T and A1298G Polymorphism in Chronic Periodontitis. J Clin Pract Res. 2019;41(3):250-254. doi:10.14744/etd.2019.39259.
Meng Y, Liu X, Ma K, Zhang L, Lu M, Zhao M, Guan MX, Qin G. Association of MTHFR C677T polymorphism and type 2 diabetes mellitus (T2DM) susceptibility. Mol Genet Genomic Med. 2019 Dec;7(12):e1020. doi: 10.1002/mgg3.1020. Epub 2019 Oct 30.
PubMed 31663297Dias LNDS, Coelho MC, Persuhn DC, Ribeiro ILA, Freire EAM, Oliveira NFP, Aquino SG. DNMT3B (rs2424913) polymorphism is associated with systemic lupus erythematosus alone and with co-existing periodontitis in a Brazilian population. J Appl Oral Sci. 2022 Apr 29;30:e20210567. doi: 10.1590/1678-7757-2021-0567. eCollection 2022.
PubMed 35507987Coelho MC, Queiroz IC, Viana Filho JMC, Aquino SG, Persuhn DC, Oliveira NFP. miR-9-1 gene methylation and DNMT3B (rs2424913) polymorphism may contribute to periodontitis. J Appl Oral Sci. 2020 Apr 3;28:e20190583. doi: 10.1590/1678-7757-2019-0583. eCollection 2020.
PubMed 32267380
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis
- ClinicalTrials.gov ID
- NCT07905209
- Acronym / sponsor ID
- TBAEK-336
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus (DM)
- Keywords
- MTHFR Gene Polymorphism, DNMT3B Gene Polymorphism, Genetic Suspectibility, Periodontal Clinical Parameters, DNA Methylation, Type 2 Diabetes Mellitus, Periodontitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 2 Aug 2026 (actual)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 29 Oct 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 inflammatory disease that affects the tissues supporting the teeth and can lead to progressive tissue destruction. Type 2 diabetes mellitus is a metabolic disease characterized by persistently elevated blood glucose levels. These two conditions are closely related, and genetic factors may influence their development and severity.
This observational study aims to evaluate the distribution of methylenetetrahydrofolate reductase (MTHFR) and DNA methyltransferase 3B (DNMT3B) gene polymorphisms in healthy individuals, individuals with periodontitis, individuals with type 2 diabetes mellitus, and individuals with both conditions. The study also aims to investigate the associations between these genetic variations and periodontal clinical parameters.
The study includes 200 participants divided into four groups of 50 individuals each: healthy individuals, individuals with type 2 diabetes without periodontitis, individuals with periodontitis without type 2 diabetes, and individuals with both type 2 diabetes and periodontitis.
Periodontal examinations include the assessment of plaque index, gingival index, probing pocket depth, clinical attachment loss, and gingival recession. Venous blood samples are collected for molecular analysis of MTHFR and DNMT3B gene polymorphisms.
The findings may contribute to a better understanding of the potential role of genetic factors in periodontal disease and its relationship with type 2 diabetes mellitus.
Detailed description
Periodontitis is a multifactorial chronic inflammatory disease characterized by inflammation and progressive destruction of the tooth-supporting tissues. Although microbial dental plaque is the primary etiological factor, the host immune response, environmental factors, and genetic susceptibility play important roles in the initiation and progression of the disease. Variations in disease severity among individuals highlight the potential contribution of genetic factors to periodontal disease pathogenesis.
Diabetes mellitus is a metabolic disease characterized by chronic hyperglycemia. It can impair immune system functions, enhance inflammatory responses, and accelerate periodontal tissue destruction. A bidirectional relationship between periodontitis and diabetes mellitus has been established. While diabetes increases the prevalence and severity of periodontal disease, periodontitis may negatively affect glycemic control by contributing to systemic inflammation. Therefore, both diseases may influence each other through shared pathophysiological mechanisms.
In recent years, increasing attention has been given to the role of genetic and epigenetic mechanisms in the pathogenesis of these diseases. The methylenetetrahydrofolate reductase (MTHFR) gene encodes an enzyme involved in folate metabolism and plays a critical role in the regulation of homocysteine metabolism. Commonly investigated MTHFR polymorphisms, including C677T (rs1801133) and A1298C (rs1801131), may reduce enzyme activity and contribute to elevated homocysteine levels, which have been associated with inflammation, oxidative stress, and vascular dysfunction.
The DNA methyltransferase 3B (DNMT3B) gene encodes an important epigenetic regulator involved in the regulation of gene expression through DNA methylation. The -149 C>T (rs2424913) polymorphism, located in the promoter region of the DNMT3B gene, may influence gene expression and modulate inflammatory responses. Through these mechanisms, this genetic variation may contribute to the pathogenesis of periodontal disease and diabetes mellitus.
Based on these findings, MTHFR and DNMT3B gene polymorphisms may play a role in the development and progression of periodontitis and diabetes mellitus. However, studies evaluating these genetic variations together with periodontal clinical parameters remain limited.
The primary aim of this study is to investigate the distribution of MTHFR and DNMT3B gene polymorphisms among healthy individuals, individuals with periodontitis alone, individuals with type 2 diabetes mellitus alone, and individuals with both type 2 diabetes mellitus and periodontitis. Additionally, the study aims to evaluate the associations between these genetic variations and periodontal clinical parameters, including plaque index, gingival index, probing pocket depth, clinical attachment loss, and gingival recession.
This observational study is conducted at the Department of Periodontology, Faculty of Dentistry, Akdeniz University, Antalya, Türkiye. A total of 200 participants are included in four groups, each consisting of 50 individuals:
- Periodontally healthy individuals without type 2 diabetes mellitus (n=50).
- Individuals with type 2 diabetes mellitus without periodontitis (n=50).
- Individuals with periodontitis without type 2 diabetes mellitus (n=50).
- Individuals with both type 2 diabetes mellitus and periodontitis (n=50).
All participants undergo a comprehensive periodontal clinical examination. Periodontal parameters include the plaque index to assess dental plaque accumulation, gingival index to evaluate gingival inflammation, probing pocket depth to determine the depth of periodontal pockets, clinical attachment loss to assess periodontal tissue destruction, and gingival recession to determine the extent of gingival tissue recession.
Venous blood samples are collected from participants, and molecular methods are used to analyze MTHFR and DNMT3B gene polymorphisms. The collected clinical and genetic data will be statistically evaluated to investigate the associations between genetic polymorphisms and periodontal clinical parameters across the four study groups.
The results of this study may provide further insight into the potential contribution of genetic and epigenetic factors to periodontal disease and the relationship between periodontitis and type 2 diabetes mellitus.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | – | Diagnostic Test: MTHFR and DNMT3B Genetic Polymorphism AnalysisThis group consists of 50 systemically and periodontally healthy individuals without type 2 diabetes mellitus or periodontitis. Periodontal clinical parameters are evaluated, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms. |
| Type 2 Diabetes Mellitus Group | – | Diagnostic Test: MTHFR and DNMT3B Genetic Polymorphism AnalysisThis group consists of 50 individuals diagnosed with type 2 diabetes mellitus without periodontitis. Periodontal clinical parameters are evaluated, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms. |
| Periodontitis Group | – | Diagnostic Test: MTHFR and DNMT3B Genetic Polymorphism AnalysisThis group consists of 50 individuals diagnosed with periodontitis without type 2 diabetes mellitus. Periodontal clinical parameters are evaluated, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms. |
| Type 2 Diabetes and Periodontitis Group | – | Diagnostic Test: MTHFR and DNMT3B Genetic Polymorphism AnalysisThis group consists of 50 individuals diagnosed with both type 2 diabetes mellitus and periodontitis. Periodontal clinical parameters are evaluated, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 200 adults recruited from the Department of Periodontology, Faculty of Dentistry, Akdeniz University, Antalya, Türkiye. Participants are divided into four groups of 50 individuals each: systemically and periodontally healthy controls, individuals with type 2 diabetes mellitus without periodontitis, individuals with periodontitis without type 2 diabetes mellitus, and individuals with both type 2 diabetes mellitus and periodontitis. Periodontal clinical parameters are recorded, and venous blood samples are collected for the analysis of MTHFR and DNMT3B gene polymorphisms.
Key inclusion criteria (6 listed)
- Being a non-smoker.
- Having received no periodontal treatment within the last 6 months.
- Having no systemic disease known to affect periodontal health other than diabetes mellitus (e.g., hypertension, cardiovascular diseases).
- Having no infectious diseases such as tuberculosis, hepatitis, or AIDS.
- Being 18 years of age or older.
Key exclusion criteria (7 listed)
- Current smokers.
- Individuals who have received periodontal treatment within the last 6 months.
- Individuals with systemic diseases known to affect periodontal health other than diabetes mellitus (e.g., hypertension, cardiovascular diseases).
- Individuals with infectious diseases such as tuberculosis, hepatitis, or AIDS.
- Individuals under 18 years of age.
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 |
|---|---|---|
| MTHFR and DNMT3B Genetic Polymorphism AnalysisVenous blood samples are collected from participants in all four study groups. DNA extracted from these samples is analyzed to identify MTHFR (C677T and A1298C) and DNMT3B (-149 C>T) gene polymorphisms. The genetic findings will be evaluated in relation to periodontal clinical parameters and the presence of type 2 diabetes mellitus and periodontitis. No therapeutic intervention is administered as part of this observational study. | Diagnostic test | Healthy Control Group, Periodontitis Group, Type 2 Diabetes Mellitus Group, Type 2 Diabetes and Periodontitis Group |
Primary outcome
MTHFR C677T (rs1801133) Genotype Distribution
Time frame: At baseline (single blood sample collection)
The distribution of MTHFR C677T (rs1801133) genotypes (CC, CT, and TT) will be determined using DNA extracted from venous blood samples. Genotype frequencies will be compared among the four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both conditions.
MTHFR A1298C (rs1801131) Genotype Distribution
Time frame: At baseline (single blood sample collection)
The distribution of MTHFR A1298C (rs1801131) genotypes (AA, AC, and CC) will be determined using DNA extracted from venous blood samples. Genotype frequencies will be compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
DNMT3B -149C>T (rs2424913) Genotype Distribution
Time frame: At baseline (single blood sample collection)
The distribution of DNMT3B -149C>T (rs2424913) genotypes (CC, CT, and TT) will be determined using DNA extracted from venous blood samples. Genotype frequencies will be compared among four study groups: healthy individuals, individuals with type 2 diabetes mellitus only, individuals with periodontitis only, and individuals with both type 2 diabetes mellitus and periodontitis.
5 secondary outcomes
Plaque Index (PI) Score
Time frame: At baseline (single periodontal examination)
Gingival Index (GI) Score
Time frame: At baseline (single periodontal examination)
Probing Pocket Depth (PPD)
Time frame: At baseline (single periodontal examination)
Clinical Attachment Loss (CAL)
Time frame: At baseline (single periodontal examination)
Gingival Recession (GR)
Time frame: At baseline (single periodontal examination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- BackgroundKocaman G, Orbak R. Investigation of the Methylenetetrahydrofolate Reductase Gene C677T and A1298G Polymorphism in Chronic Periodontitis. J Clin Pract Res. 2019;41(3):250-254. doi:10.14744/etd.2019.39259.
- Background: PubMed 31663297Meng Y, Liu X, Ma K, Zhang L, Lu M, Zhao M, Guan MX, Qin G. Association of MTHFR C677T polymorphism and type 2 diabetes mellitus (T2DM) susceptibility. Mol Genet Genomic Med. 2019 Dec;7(12):e1020. doi: 10.1002/mgg3.1020. Epub 2019 Oct 30.
- Background: PubMed 35507987Dias LNDS, Coelho MC, Persuhn DC, Ribeiro ILA, Freire EAM, Oliveira NFP, Aquino SG. DNMT3B (rs2424913) polymorphism is associated with systemic lupus erythematosus alone and with co-existing periodontitis in a Brazilian population. J Appl Oral Sci. 2022 Apr 29;30:e20210567. doi: 10.1590/1678-7757-2021-0567. eCollection 2022.
- Background: PubMed 32267380Coelho MC, Queiroz IC, Viana Filho JMC, Aquino SG, Persuhn DC, Oliveira NFP. miR-9-1 gene methylation and DNMT3B (rs2424913) polymorphism may contribute to periodontitis. J Appl Oral Sci. 2020 Apr 3;28:e20190583. doi: 10.1590/1678-7757-2019-0583. eCollection 2020.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers due to participant confidentiality and the sensitive nature of genetic and clinical health information. The collected data will be used exclusively for the purposes of the approved research study. Study findings will be reported in aggregate form without disclosing individual participant information.
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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.
Nezahat Arzu Kayar, DDS, PhD principal investigator
Akdeniz University, Faculty of Dentistry, Department of Periodontology
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 Periodontitis and Type 2 Diabetes Mellitus (DM), run by Akdeniz 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 6 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
MTHFR C677T (rs1801133) Genotype Distribution (time frame: At baseline (single blood sample collection)). The study lists 3 primary outcomes in all. 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 NCT07905209, which also lists 4 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 29 Oct 2026.