Periodontal DiseasesNCT07504744
Klotho Gene, Red Complex Bacteria and Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome
An observational study of Periodontal Diseases and Acute Coronary Artery Disease, run by Meenakshi Ammal Dental College and Hospital.
Trial summary
The Klotho gene was initially identified as an aging suppressor gene, but subsequent research revealed its multifaceted functions, encompassing antioxidant defense, anti-inflammatory effects, calcium and phosphorus balance, metabolic regulation, and anti-apoptotic activity. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Acute Coronary Artery Disease
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2026to 9 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: GROUP I * Systemically healthy subjects with healthy periodontium having probing pocket depth (PPD) ≤ 3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites. GROUP II * Systemically healthy subjects with periodontitis having interdental clinical attachment loss ≥ 3-5mm (stage II/III periodontitis) and probing pocket depth (PPD) ≥ 5mm (stage I/III periodontitis) and bleeding on probing ≥ 10% of sites. GROUP III * Patients diagnosed with acute coronary syndrome with healthy periodontium having probing pocket depth (PPD) ≤ 3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites GROUP IV * Acute coronary syndrome patients with periodontitis having interdental clinical attachment loss ≥ 3-5mm (stage II/III periodontitis) and probing pocket depth (PPD) ≥ 5mm (stage II/III periodontitis) and bleeding on probing ≥ 10%.
Who may be able to join
- Patients willing to participate in the study.
- Male and female patients within the age group of 30-65 years.
- Patients having ≥ 10 remaining natural teeth.
- No history of long-term antibiotic use in past 6 months.
Who cannot join
- Subjects with systemic conditions such as type I and type I diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies/neoplasm and HIV infection will be excluded from the present investigation.
- Subjects on drugs such as corticosteroids or antibiotics within 6 months of investigation or antiepileptic drugs (phenytoin or cyclosporine) having an impact on periodontal tissues will be excluded.
- Pregnant women (pregnancy may alter the oral flora).
- Current smokers and individuals who quit smoking less than 6 months.
- Patients who have undergone periodontal therapy within the previous 6 months
About this study
Official title: Evaluation of the Expression of Klotho Gene and Its Protein Level, Determination of Red Complex Bacteria, and the Estimation of Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome
The Klotho gene was initially identified as an aging suppressor gene, but subsequent research revealed its multifaceted functions, encompassing antioxidant defense, anti-inflammatory effects, calcium and phosphorus balance, metabolic regulation, and anti-apoptotic activity. It encodes a single pass transmembrane protein and is expressed primarily in renal tubules. The Klotho protein exists in two forms: membrane-bound and secreted. Membrane Klotho acts as a co-receptor for FGF23, a bone-derived hormone, while secreted Klotho regulates various cell surface glycoproteins, including ion channels and growth factor receptors. Klotho has recently emerged as a potential biomarker for coronary heart disease, with evidence suggesting its involvement in the disease's pathophysiology.
The red complex, comprising Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia harbors key pathogens in adult periodontal disease. These bacteria possess various virulence factors, including fimbriae, lipopolysaccharides, and proteases in P. gingivalis, which disrupt inflammatory and immune responses and degrade connective tissue proteins. T. forsythia produces a trypsin-like protease, sialidase, hemagglutinin, and BspA, contributing to alveolar bone loss. Meanwhile, T. denticola disrupts the host cell extracellular matrix, penetrates tissue, and dysregulates immunoregulatory factors, further exacerbating periodontal disease. Similarly, Herpes Simplex Virus 1 (HSV-1), human Cytomegalovirus (HCMV) and Epstein Barr Virus (EBV) have been implicated in the pathogenesis of periodontal disease. The expressions of viruses along the red complex bacteria would provide further evidence of periodontal risk in progression of acute coronary artery disease.
Read the detailed description
The selected subjects will be categorized into the following groups:
GROUP I: Healthy volunteers. GROUP II: Periodontitis patients without acute coronary syndrome. GROUP III: Acute coronary syndrome without periodontitis GROUP IV: Periodontitis and acute coronary syndrome
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described | |
| Periodontitis patients without acute coronary syndrome | Not described | |
| Acute coronary syndrome patients without periodontitis | Not described | |
| Periodontitis and acute coronary syndrome patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in periodontal parameters
Change in periodontal probing depth (measured in mm higher value indicate disease progression)
Measured: Baseline-24 months
Change in periodontal variables
Change in Clinical attachment level (measured in mm higher value indicate disease progression)
Measured: Baseline - 2 years
Change in periodontal criteria
Change in plaque index (measured as a ratio, range: 0 to 3, maximum value indicates worse outcome and minimum value indicates better outcome)
Measured: Baseline - 2 years
Change in periodontal variables
Changes in Gingival index (measure as a ratio, (0-3)higher value indicates severity of gingival inflammation)
Measured: Baseline - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start5 Oct 2026 (estimated)
- Primary completion3 Nov 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Other
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meenakshi Ammal Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504744
- Sponsor's protocol ID
- MADC/IEC/I/28/2025
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Expression of Klotho Gene and Its Protein Level, Determination of Red Complex Bacteria, and the Estimation of Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07504744
- Acronym / sponsor ID
- MADC/IEC/I/28/2025
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 3 Nov 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 1 Apr 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.
The Klotho gene was initially identified as an aging suppressor gene, but subsequent research revealed its multifaceted functions, encompassing antioxidant defense, anti-inflammatory effects, calcium and phosphorus balance, metabolic regulation, and anti-apoptotic activity. It encodes a single pass transmembrane protein and is expressed primarily in renal tubules. The Klotho protein exists in two forms: membrane-bound and secreted. Membrane Klotho acts as a co-receptor for FGF23, a bone-derived hormone, while secreted Klotho regulates various cell surface glycoproteins, including ion channels and growth factor receptors. Klotho has recently emerged as a potential biomarker for coronary heart disease, with evidence suggesting its involvement in the disease's pathophysiology.
The red complex, comprising Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia harbors key pathogens in adult periodontal disease. These bacteria possess various virulence factors, including fimbriae, lipopolysaccharides, and proteases in P. gingivalis, which disrupt inflammatory and immune responses and degrade connective tissue proteins. T. forsythia produces a trypsin-like protease, sialidase, hemagglutinin, and BspA, contributing to alveolar bone loss. Meanwhile, T. denticola disrupts the host cell extracellular matrix, penetrates tissue, and dysregulates immunoregulatory factors, further exacerbating periodontal disease. Similarly, Herpes Simplex Virus 1 (HSV-1), human Cytomegalovirus (HCMV) and Epstein Barr Virus (EBV) have been implicated in the pathogenesis of periodontal disease. The expressions of viruses along the red complex bacteria would provide further evidence of periodontal risk in progression of acute coronary artery disease.
Detailed description
The selected subjects will be categorized into the following groups:
GROUP I: Healthy volunteers. GROUP II: Periodontitis patients without acute coronary syndrome. GROUP III: Acute coronary syndrome without periodontitis GROUP IV: Periodontitis and acute coronary syndrome
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| Periodontitis patients without acute coronary syndrome | – | – |
| Acute coronary syndrome patients without periodontitis | – | – |
| Periodontitis and acute coronary syndrome patients | – | – |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- GROUP I * Systemically healthy subjects with healthy periodontium having probing pocket depth (PPD) ≤ 3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites. GROUP II * Systemically healthy subjects with periodontitis having interdental clinical attachment loss ≥ 3-5mm (stage II/III periodontitis) and probing pocket depth (PPD) ≥ 5mm (stage I/III periodontitis) and bleeding on probing ≥ 10% of sites. GROUP III * Patients diagnosed with acute coronary syndrome with healthy periodontium having probing pocket depth (PPD) ≤ 3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites GROUP IV * Acute coronary syndrome patients with periodontitis having interdental clinical attachment loss ≥ 3-5mm (stage II/III periodontitis) and probing pocket depth (PPD) ≥ 5mm (stage II/III periodontitis) and bleeding on probing ≥ 10%.
Key inclusion criteria (4 listed)
- Patients willing to participate in the study.
- Male and female patients within the age group of 30-65 years.
- Patients having ≥ 10 remaining natural teeth.
- No history of long-term antibiotic use in past 6 months.
Key exclusion criteria (5 listed)
- Subjects with systemic conditions such as type I and type I diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies/neoplasm and HIV infection will be excluded from the present investigation.
- Subjects on drugs such as corticosteroids or antibiotics within 6 months of investigation or antiepileptic drugs (phenytoin or cyclosporine) having an impact on periodontal tissues will be excluded.
- Pregnant women (pregnancy may alter the oral flora).
- Current smokers and individuals who quit smoking less than 6 months.
- Patients who have undergone periodontal therapy within the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in periodontal parameters
Time frame: Baseline-24 months
Change in periodontal probing depth (measured in mm higher value indicate disease progression)
Change in periodontal variables
Time frame: Baseline - 2 years
Change in Clinical attachment level (measured in mm higher value indicate disease progression)
Change in periodontal criteria
Time frame: Baseline - 2 years
Change in plaque index (measured as a ratio, range: 0 to 3, maximum value indicates worse outcome and minimum value indicates better outcome)
Change in periodontal variables
Time frame: Baseline - 2 years
Changes in Gingival index (measure as a ratio, (0-3)higher value indicates severity of gingival inflammation)
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 8 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Acute Coronary Artery Disease, run by Meenakshi Ammal Dental College and Hospital.
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 5 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in periodontal parameters (time frame: Baseline-24 months). The study lists 4 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 8 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.