PeriodontitisNCT07353606
Cofilin-2 (rs80358250) and Lactoferrin (rs1126478) Polymorphism and Protein Levels With Non Surgical Periodontal Therapy in Periodontitis Patients With and Without CHD
A study testing Scaling and root planing in people with Periodontitis and Chronic Periodontitis (Disorder), run by Meenakshi Ammal Dental College and Hospital at 2 sites in India.
Trial summary
Periodontitis is a chronic multifactorial inflammatory disease associated with the accumulation of dental plaque and characterized by progressive destruction of the teeth-supporting apparatus, including the periodontal ligament and alveolar bone. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Chronic Periodontitis (Disorder), Coronary Heart Disease
- What is being tested?
- Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesIndia
- Study dates
- 20 Nov 2024to 20 Apr 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patient willing to participate in the study.
- Male and female patients with the age group of 30 to 65 years.
- Patient having more than or equal to 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 II 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Kilpauk medical college and hospital
Chennai, Tamil Nadu, 600095
Meenakshi Ammal Dental College and hospital
Chennai, Tamil Nadu, 600095
About this study
Official title: Determination of Cofilin-2 (rs80358250) and Lactoferrin (rs1126478) Genetic Polymorphism and Change in Their Protein Levels Before and After Non-surgical Periodontal Therapy in Periodontitis Patients With and Without Coronary Heart Disease - An Interventional Study.
Periodontitis is a chronic multifactorial inflammatory disease associated with the accumulation of dental plaque and characterized by progressive destruction of the teeth-supporting apparatus, including the periodontal ligament and alveolar bone. Dental plaque accumulation at the gingival margin initiates an inflammatory response that, in turn, causes microbial alterations and may lead to drastic consequences in the periodontium of susceptible individuals. The pathophysiology of periodontitis is influenced by the relationship between the host immune system and periodontal pathogens. The presence of periodontal pathogens and their metabolic by-products in the oral cavity may get disseminated to the systemic circulation which may pose a risk for various systemic diseases such as cardiovascular disease, oral and colorectal cancer, gastrointestinal diseases, respiratory tract infection, adverse pregnancy outcomes and diabetes.
Although pathogenic bacteria and various other environmental factors are involved in pathogenesis of periodontitis, genetic factors are also known to play a pivotal role in influencing the inflammatory and immune response. Genetic polymorphisms are alterations in the DNA sequence found in general population. Most forms of periodontitis represent a life-long account of interactions between the genome and the environment. The previous literature has stated a strong association of genetic polymorphisms in periodontitis and coronary artery diseases. Identifying these polymorphisms can potentially lead to a better understanding of the mechanisms modulating the expression of inflammatory mediators as well as provides potential therapeutic targets in the prevention of periodontal disease. Two such novel polymorphisms have gained attention recently, namely the Cofilin-2 and Lactoferrin polymorphisms.
Read more
Cofilin is one of the most affluent and common actin-binding proteins and plays a role in cell motility, migration, shape, and metabolism. They also play an important role in severing actin filament, nucleating, depolymerizing and bundling activities. Cofilin is the major ADF/cofilin isoform in mammalian neurons influences the dynamics of actin assembly by severing or stabilizing actin filaments. Cofilin-2 is the only isoform present in mature skeletal muscles. It is composed of 5 α helices, 5 β sheets, and 1 C-terminal β short chain, with a molecular weight of 18 kDa. Cofilin-2 is a member of the AC group of proteins that also includes cofilin-1 and destrin, all of which regulate actin-filament dynamics. Recently, Cofilin 2 gained attention as an emerging biomarker for coronary heart diseases. Cofilin-2 has shown to play a role in pathophysiology of coronary heart disease.
Lactoferrin is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears and nasal secretions. Lactoferrin, a multifunctional iron-binding glycoprotein, is involved in coronary heart disease pathophysiology. Recent studies reported that Lactoferrin polymorphism is associated with an increased risk of coronary artery disease in the elderly population.
Studies have been done to identify Lactoferrin genetic polymorphisms, however none of the studies have explored the role of Lactoferrin (rs1126478) and its protein level in subjects with both periodontal disease and coronary heart disease occurring as a continuum. Its expression in periodontitis and coronary heart disease patients is yet to be explored. Genetic polymorphism and protein levels of Cofilin-2 (rs80358250) has been never studied in coronary heart disease and periodontitis. This may further improve our understanding of the influence of this polymorphism on the above mentioned systemic diseases.
NEED FOR THE STUDY While there are studies which have demonstrated the expression of Cofilin-2 and Lactoferrin polymorphisms in various inflammatory conditions, there are no studies to state their expression in the subgingival plaque samples of periodontitis patients with coronary artery disease, specifically before and after non-surgical therapy. Also, the correlation of both these polymorphisms and their levels with periodontal and cardiac parameters has never been investigated so far. It is suggested that these polymorphisms may play a role as putative risk indicators in periodontitis subjects with coronary heart disease which may alter following non-surgical periodontal therapy.
- Being tested
- Scaling and root planing
- Keywords
- chronic periodontitis, coronary heart disease, cofillin-2, lactoferrin
- Medical subject headings
- Periodontitis, Chronic Periodontitis, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Scaling and root planing is a deep cleaning below the gumline used to treat gum disease. Gum disease is caused by a sticky film of bacteria called plaque. Plaque is always forming on your teeth, but if they aren't cleaned well, the bacteria in plaque can cause your gums to become inflammed.
| Study group | Role | What they receive |
|---|---|---|
| GROUP I: 21 systemically healthy subjects with healthy periodontium. | Experimental | 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. Receives: Procedure: Scaling and root planing |
| GROUP II: 21 periodontitis patients without coronary heart disease | Experimental | Systemically healthy subjects 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% of sites. Receives: Procedure: Scaling and root planing |
| GROUP III: 21 coronary heart disease patients without periodontitis | Experimental | Patients diagnosed with coronary artery disease with healthy periodontium having probing pocket depth (PPD)≤3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites (CAD). Receives: Procedure: Scaling and root planing |
| Group IV: 21 periodontitis patients with coronary heart disease. | Experimental | Coronary heart disease (CHD) 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%. Receives: Procedure: Scaling and root planing |
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 posted20 Jan 2026
- Study start20 Nov 2024
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 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
- NCT07353606
- Sponsor's protocol ID
- MADCH/IEC-II/48/2024
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng Q, Fang Q, Zhou X, Yang H, Dou Y, Zhang W, Gong P, Rong X. Cofilin 2 Acts as an Inflammatory Linker Between Chronic Periodontitis and Alzheimer's Disease in Amyloid Precursor Protein/Presenilin 1 Mice. Front Mol Neurosci. 2021 Sep 30;14:728184. doi: 10.3389/fnmol.2021.728184. eCollection 2021.
PubMed 34658785Nguyen K, Chau VQ, Mauro AG, Durrant D, Toldo S, Abbate A, Das A, Salloum FN. Hydrogen Sulfide Therapy Suppresses Cofilin-2 and Attenuates Ischemic Heart Failure in a Mouse Model of Myocardial Infarction. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):472-483. doi: 10.1177/1074248420923542. Epub 2020 May 11.
PubMed 32390525
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Cofilin-2 (rs80358250) and Lactoferrin (rs1126478) Genetic Polymorphism and Change in Their Protein Levels Before and After Non-surgical Periodontal Therapy in Periodontitis Patients With and Without Coronary Heart Disease - An Interventional Study.
- ClinicalTrials.gov ID
- NCT07353606
- Acronym / sponsor ID
- MADCH/IEC-II/48/2024
- Keywords
- chronic periodontitis, coronary heart disease, cofillin-2, lactoferrin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 20 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 multifactorial inflammatory disease associated with the accumulation of dental plaque and characterized by progressive destruction of the teeth-supporting apparatus, including the periodontal ligament and alveolar bone. Dental plaque accumulation at the gingival margin initiates an inflammatory response that, in turn, causes microbial alterations and may lead to drastic consequences in the periodontium of susceptible individuals. The pathophysiology of periodontitis is influenced by the relationship between the host immune system and periodontal pathogens. The presence of periodontal pathogens and their metabolic by-products in the oral cavity may get disseminated to the systemic circulation which may pose a risk for various systemic diseases such as cardiovascular disease, oral and colorectal cancer, gastrointestinal diseases, respiratory tract infection, adverse pregnancy outcomes and diabetes.
Although pathogenic bacteria and various other environmental factors are involved in pathogenesis of periodontitis, genetic factors are also known to play a pivotal role in influencing the inflammatory and immune response. Genetic polymorphisms are alterations in the DNA sequence found in general population. Most forms of periodontitis represent a life-long account of interactions between the genome and the environment. The previous literature has stated a strong association of genetic polymorphisms in periodontitis and coronary artery diseases. Identifying these polymorphisms can potentially lead to a better understanding of the mechanisms modulating the expression of inflammatory mediators as well as provides potential therapeutic targets in the prevention of periodontal disease. Two such novel polymorphisms have gained attention recently, namely the Cofilin-2 and Lactoferrin polymorphisms.
Cofilin is one of the most affluent and common actin-binding proteins and plays a role in cell motility, migration, shape, and metabolism. They also play an important role in severing actin filament, nucleating, depolymerizing and bundling activities. Cofilin is the major ADF/cofilin isoform in mammalian neurons influences the dynamics of actin assembly by severing or stabilizing actin filaments. Cofilin-2 is the only isoform present in mature skeletal muscles. It is composed of 5 α helices, 5 β sheets, and 1 C-terminal β short chain, with a molecular weight of 18 kDa. Cofilin-2 is a member of the AC group of proteins that also includes cofilin-1 and destrin, all of which regulate actin-filament dynamics. Recently, Cofilin 2 gained attention as an emerging biomarker for coronary heart diseases. Cofilin-2 has shown to play a role in pathophysiology of coronary heart disease.
Lactoferrin is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears and nasal secretions. Lactoferrin, a multifunctional iron-binding glycoprotein, is involved in coronary heart disease pathophysiology. Recent studies reported that Lactoferrin polymorphism is associated with an increased risk of coronary artery disease in the elderly population.
Studies have been done to identify Lactoferrin genetic polymorphisms, however none of the studies have explored the role of Lactoferrin (rs1126478) and its protein level in subjects with both periodontal disease and coronary heart disease occurring as a continuum. Its expression in periodontitis and coronary heart disease patients is yet to be explored. Genetic polymorphism and protein levels of Cofilin-2 (rs80358250) has been never studied in coronary heart disease and periodontitis. This may further improve our understanding of the influence of this polymorphism on the above mentioned systemic diseases.
NEED FOR THE STUDY While there are studies which have demonstrated the expression of Cofilin-2 and Lactoferrin polymorphisms in various inflammatory conditions, there are no studies to state their expression in the subgingival plaque samples of periodontitis patients with coronary artery disease, specifically before and after non-surgical therapy. Also, the correlation of both these polymorphisms and their levels with periodontal and cardiac parameters has never been investigated so far. It is suggested that these polymorphisms may play a role as putative risk indicators in periodontitis subjects with coronary heart disease which may alter following non-surgical periodontal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP I: 21 systemically healthy subjects with healthy periodontium. | Experimental | Procedure: Scaling and root planingSystemically 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: 21 periodontitis patients without coronary heart disease | Experimental | Procedure: Scaling and root planingSystemically healthy subjects 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% of sites. |
| GROUP III: 21 coronary heart disease patients without periodontitis | Experimental | Procedure: Scaling and root planingPatients diagnosed with coronary artery disease with healthy periodontium having probing pocket depth (PPD)≤3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites (CAD). |
| Group IV: 21 periodontitis patients with coronary heart disease. | Experimental | Procedure: Scaling and root planingCoronary heart disease (CHD) 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 qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient willing to participate in the study.
- Male and female patients with the age group of 30 to 65 years.
- Patient having more than or equal to 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 II 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and root planingScaling and root planing is a deep cleaning below the gumline used to treat gum disease. Gum disease is caused by a sticky film of bacteria called plaque. Plaque is always forming on your teeth, but if they aren't cleaned well, the bacteria in plaque can cause your gums to become inflammed. | Procedure or surgery | GROUP I: 21 systemically healthy subjects with healthy periodontium., GROUP II: 21 periodontitis patients without coronary heart disease, GROUP III: 21 coronary heart disease patients without periodontitis, Group IV: 21 periodontitis patients with coronary heart disease. |
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 22 Jan 2026.
- Background: PubMed 34658785Zeng Q, Fang Q, Zhou X, Yang H, Dou Y, Zhang W, Gong P, Rong X. Cofilin 2 Acts as an Inflammatory Linker Between Chronic Periodontitis and Alzheimer's Disease in Amyloid Precursor Protein/Presenilin 1 Mice. Front Mol Neurosci. 2021 Sep 30;14:728184. doi: 10.3389/fnmol.2021.728184. eCollection 2021.
- Background: PubMed 32390525Nguyen K, Chau VQ, Mauro AG, Durrant D, Toldo S, Abbate A, Das A, Salloum FN. Hydrogen Sulfide Therapy Suppresses Cofilin-2 and Attenuates Ischemic Heart Failure in a Mouse Model of Myocardial Infarction. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):472-483. doi: 10.1177/1074248420923542. Epub 2020 May 11.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing in people with Periodontitis and Chronic Periodontitis (Disorder), run by Meenakshi Ammal Dental College and Hospital at 2 sites in India.
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: under way, not looking for participants, as of the sponsor's last update on 22 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 2 sites in India. 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?
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?
On the ClinicalTrials.gov record for NCT07353606, which also lists 2 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 22 Jan 2026.