HypertensionNCT07873385
Evaluation of MTHFR Gene Polymorphism and Periodontal Clinical Parameters in Healthy, Hypertensive, and Periodontitis Individuals
An observational study of Hypertension and Periodontitis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate the relationship between MTHFR gene polymorphisms and periodontal clinical findings in healthy individuals, individuals with hypertension, individuals with periodontitis, and individuals with both hypertension and periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Periodontitis
- What is being tested?
- MTHFR Gene Polymorphism Analysis
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2026to 27 Sep 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18 years or older who meet the eligibility criteria will be included in the study. A total of 200 participants will be included in four groups: healthy individuals, individuals with hypertension, individuals with periodontitis, and individuals with both hypertension and periodontitis, with 50 participants in each group. Participants will undergo periodontal clinical examination and venous blood sampling for MTHFR gene polymorphism analysis.
Who may be able to join
- Age 18 years or older.
- Nonsmokers.
- No periodontal treatment within the previous 6 months.
- No systemic disease affecting periodontal health other than hypertension.
- No tuberculosis, hepatitis, or AIDS.
- Not pregnant.
Show all 12Show fewer
- Age 18 years or older.
- Nonsmokers.
- No periodontal treatment within the previous 6 months.
- No systemic disease affecting periodontal health other than hypertension.
- No tuberculosis, hepatitis, or AIDS.
- Not pregnant.
Who cannot join
- none
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
Official title: Evaluation of MTHFR Gene Polymorphism Along With Periodontal Clinical Parameters in Healthy, Hypertensive, and Periodontitis Individuals
This observational study aims to evaluate the relationship between MTHFR gene polymorphisms and periodontal clinical findings in healthy individuals, individuals with hypertension, individuals with periodontitis, and individuals with both hypertension and periodontitis. A total of 200 participants will be included in four groups of 50 participants each. Periodontal clinical measurements, including plaque index, gingival index, bleeding on probing, probing depth, and clinical attachment level, will be recorded. Venous blood samples will be collected for DNA isolation and analysis of MTHFR gene polymorphisms. The study will investigate whether MTHFR gene polymorphisms are associated with periodontal clinical parameters and hypertension.
Read the detailed description
This is a single-center observational study conducted at the Department of Periodontology, Faculty of Dentistry, Akdeniz University. The study includes four groups: healthy individuals, individuals with hypertension without periodontitis, individuals with periodontitis without hypertension, and individuals with both hypertension and periodontitis. A total of 200 participants will be included, with 50 participants planned for each group.
Periodontal clinical parameters will be assessed using a periodontal probe and will include plaque index, gingival index, bleeding on probing, probing depth, clinical attachment level, and gingival recession. Periodontal status will be classified according to the 2018 EFP/AAP classification. Venous blood samples will be collected from the participants, followed by DNA isolation and molecular analysis of MTHFR gene polymorphisms using polymerase chain reaction (PCR)-based methods.
The study population will consist of adults aged 18 years or older. Participants will be required to be nonsmokers, have no periodontal treatment within the previous six months, and have no systemic disease affecting periodontal health other than hypertension. Individuals with tuberculosis, hepatitis, or AIDS and pregnant individuals will not be included.
The study aims to evaluate the association between MTHFR gene polymorphisms, hypertension, and periodontal clinical parameters. Statistical analyses will be performed using appropriate statistical methods, with statistical significance set at p < 0.05.
- Conditions
- Hypertension, Periodontitis
- Being tested
- MTHFR Gene Polymorphism Analysis
- Keywords
- MTHFR gene polymorphism, Periodontal clinical parameters, Periodontitis, Hypertension, Periodontal disease
- Medical subject headings
- Hypertension, Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTHFR Gene Polymorphism AnalysisOther
Participants will undergo venous blood sampling, DNA isolation, and analysis of MTHFR gene polymorphisms. No therapeutic intervention is assigned to participants; the study is observational.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals | This group consists of 50 healthy individuals without hypertension or periodontitis. Participants will undergo periodontal clinical examinations and venous blood sampling for MTHFR gene polymorphism analysis. Receives: Other: MTHFR Gene Polymorphism Analysis | |
| Individuals with Hypertension | This group consists of 50 individuals with hypertension without periodontitis. Participants will undergo periodontal clinical examinations and venous blood sampling for MTHFR gene polymorphism analysis. Receives: Other: MTHFR Gene Polymorphism Analysis | |
| Individuals with Periodontitis | This group consists of 50 individuals with periodontitis without hypertension. Participants will undergo periodontal clinical examinations and venous blood sampling for MTHFR gene polymorphism analysis. Receives: Other: MTHFR Gene Polymorphism Analysis | |
| Individuals with Hypertension and Periodontitis | This group consists of 50 individuals with both hypertension and periodontitis. Participants will undergo periodontal clinical examinations and venous blood sampling for MTHFR gene polymorphism analysis. Receives: Other: MTHFR Gene Polymorphism Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (Silness & Löe)
Dental plaque accumulation assessed using the Silness \& Löe Plaque Index. Scores range from 0 to 3; higher scores indicate greater plaque accumulation
Measured: At baseline periodontal examination
Gingival Index (Löe & Sillnes)
Gingival inflammation assessed using the Löe \& Silness Gingival Index. Scores range from 0 to 3; higher scores indicate more severe inflammation.
Measured: At baseline periodontal examination
Bleeding on Probing (BOP)
Percentage of sites showing bleeding within 30 seconds after gentle probing. Reported as percentage of examined sites (%).
Measured: At baseline periodontal examination
Probing Depth (PD)
Distance from the gingival margin to the base of the periodontal pocket, measured with a periodontal probe at six sites per tooth. Reported as mean value in millimeters (mm).
Measured: At baseline periodontal examination
Clinical Attachment Level (CAL)
Distance from the cemento-enamel junction to the base of the periodontal pocket, measured at six sites per tooth. Reported as mean value in millimeters (mm).
Measured: At baseline periodontal examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start27 Mar 2026
- Primary completion27 Sep 2026
- Study completion27 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873385
- Sponsor's protocol ID
- AKD-TBAEK-2
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MTHFR Gene Polymorphism Along With Periodontal Clinical Parameters in Healthy, Hypertensive, and Periodontitis Individuals
- ClinicalTrials.gov ID
- NCT07873385
- Acronym / sponsor ID
- AKD-TBAEK-2
- Conditions
- Hypertension, Periodontitis
- Keywords
- MTHFR gene polymorphism, Periodontal clinical parameters, Periodontitis, Hypertension, Periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 27 Sep 2026 (actual)
- Study completion
- 27 Sep 2026 (actual)
- First posted
- 14 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.
This observational study aims to evaluate the relationship between MTHFR gene polymorphisms and periodontal clinical findings in healthy individuals, individuals with hypertension, individuals with periodontitis, and individuals with both hypertension and periodontitis. A total of 200 participants will be included in four groups of 50 participants each. Periodontal clinical measurements, including plaque index, gingival index, bleeding on probing, probing depth, and clinical attachment level, will be recorded. Venous blood samples will be collected for DNA isolation and analysis of MTHFR gene polymorphisms. The study will investigate whether MTHFR gene polymorphisms are associated with periodontal clinical parameters and hypertension.
Detailed description
This is a single-center observational study conducted at the Department of Periodontology, Faculty of Dentistry, Akdeniz University. The study includes four groups: healthy individuals, individuals with hypertension without periodontitis, individuals with periodontitis without hypertension, and individuals with both hypertension and periodontitis. A total of 200 participants will be included, with 50 participants planned for each group.
Periodontal clinical parameters will be assessed using a periodontal probe and will include plaque index, gingival index, bleeding on probing, probing depth, clinical attachment level, and gingival recession. Periodontal status will be classified according to the 2018 EFP/AAP classification. Venous blood samples will be collected from the participants, followed by DNA isolation and molecular analysis of MTHFR gene polymorphisms using polymerase chain reaction (PCR)-based methods.
The study population will consist of adults aged 18 years or older. Participants will be required to be nonsmokers, have no periodontal treatment within the previous six months, and have no systemic disease affecting periodontal health other than hypertension. Individuals with tuberculosis, hepatitis, or AIDS and pregnant individuals will not be included.
The study aims to evaluate the association between MTHFR gene polymorphisms, hypertension, and periodontal clinical parameters. Statistical analyses will be performed using appropriate statistical methods, with statistical significance set at p < 0.05.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals | – | Other: MTHFR Gene Polymorphism AnalysisThis group consists of 50 healthy individuals without hypertension or periodontitis. Participants will undergo periodontal clinical examinations and venous blood sampling for MTHFR gene polymorphism analysis. |
| Individuals with Hypertension | – | Other: MTHFR Gene Polymorphism AnalysisThis group consists of 50 individuals with hypertension without periodontitis. Participants will undergo periodontal clinical examinations and venous blood sampling for MTHFR gene polymorphism analysis. |
| Individuals with Periodontitis | – | Other: MTHFR Gene Polymorphism AnalysisThis group consists of 50 individuals with periodontitis without hypertension. Participants will undergo periodontal clinical examinations and venous blood sampling for MTHFR gene polymorphism analysis. |
| Individuals with Hypertension and Periodontitis | – | Other: MTHFR Gene Polymorphism AnalysisThis group consists of 50 individuals with both hypertension and periodontitis. Participants will undergo periodontal clinical examinations and venous blood sampling for MTHFR gene polymorphism analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older who meet the eligibility criteria will be included in the study. A total of 200 participants will be included in four groups: healthy individuals, individuals with hypertension, individuals with periodontitis, and individuals with both hypertension and periodontitis, with 50 participants in each group. Participants will undergo periodontal clinical examination and venous blood sampling for MTHFR gene polymorphism analysis.
Key inclusion criteria (12 listed)
- Age 18 years or older.
- Nonsmokers.
- No periodontal treatment within the previous 6 months.
- No systemic disease affecting periodontal health other than hypertension.
- No tuberculosis, hepatitis, or AIDS.
Key exclusion criteria (1 listed)
- none
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 Gene Polymorphism AnalysisParticipants will undergo venous blood sampling, DNA isolation, and analysis of MTHFR gene polymorphisms. No therapeutic intervention is assigned to participants; the study is observational. | Other | Healthy Individuals, Individuals with Hypertension, Individuals with Hypertension and Periodontitis, Individuals with Periodontitis |
Primary outcome
Plaque Index (Silness & Löe)
Time frame: At baseline periodontal examination
Dental plaque accumulation assessed using the Silness \& Löe Plaque Index. Scores range from 0 to 3; higher scores indicate greater plaque accumulation
Gingival Index (Löe & Sillnes)
Time frame: At baseline periodontal examination
Gingival inflammation assessed using the Löe \& Silness Gingival Index. Scores range from 0 to 3; higher scores indicate more severe inflammation.
Bleeding on Probing (BOP)
Time frame: At baseline periodontal examination
Percentage of sites showing bleeding within 30 seconds after gentle probing. Reported as percentage of examined sites (%).
Probing Depth (PD)
Time frame: At baseline periodontal examination
Distance from the gingival margin to the base of the periodontal pocket, measured with a periodontal probe at six sites per tooth. Reported as mean value in millimeters (mm).
Clinical Attachment Level (CAL)
Time frame: At baseline periodontal examination
Distance from the cemento-enamel junction to the base of the periodontal pocket, measured at six sites per tooth. Reported as mean value in millimeters (mm).
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension and Periodontitis, 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 12 inclusion and 1 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 14 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?
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?
Plaque Index (Silness & Löe) (time frame: At baseline periodontal examination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.