Periodontal DiseasesNCT05828368
DKK-3 rs11544814 and CFH rs10737680 Polymorphism and Protein Levels With Non Surgical Periodontal Therapy in Periodontitis Patients With and Without CAD
A study testing Non surgical periodontal therapy in people with Periodontal Diseases, run by Meenakshi Ammal Dental College and Hospital at 2 sites in India.
Trial summary
Untreated periodontal infection may result in transient bacteremia and toxaemia which may be the cause of adverse systemic events, leading to various systemic disorders. Amongst all the systemic diseases, cardiovascular disease has been recognized as a major systemic inflammatory condition that present similarities… 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
- What is being tested?
- Non surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jun 2023to 30 Apr 2025
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 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
Meenakshi Ammal Dental college and hospital
Chennai, Tamil Nadu, 600095
Jaideep Mahendra, MDS,Ph.D Post Doc (USA), 9444963973, jaideep_m_23@yahoo.co.in
Jaideep Mahendra, MDS,Ph.D Post Doc (USA)
Frontier lifeline Hospital
Chennai, Tamil Nadu, 600101
Jaideep Mahendra
About this study
Official title: Determination of Dickkopf-3 rs11544814 and Complement Factor H rs10737680 Genetic Polymorphism and Change in Their Protein Levels Before and After Non Surgical Periodontal Therapy in Periodontitis Patients With and Without Coronary Artery Disease
Untreated periodontal infection may result in transient bacteremia and toxaemia which may be the cause of adverse systemic events, leading to various systemic disorders. Amongst all the systemic diseases, cardiovascular disease has been recognized as a major systemic inflammatory condition that present similarities with periodontal disease. Increased systemic biomarkers of inflammation associated with periodontal disease have been interpreted as a mechanistic link between periodontitis and cardiovascular diseases.
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 Dickkopf-3 and complement factor H polymorphisms.
Read more
Dickkopf-3 belongs to Dickkopf family of glycoproteins. Dickkopf-3 has been mainly investigated in oncology for its role as a tumor suppressor gene and as a therapeutic target in several types of human carcinomas. Recently, Dickkopf-3 gained attention as an emerging biomarker for cardiovascular and renal diseases. Dickkopf-3 has shown to play a role in pathophysiology of arterial wall thickening and abnormality implicated in atherosclerosis.
However, genetic polymorphism of Dickkopf-3 rs11544814 and complement factor H rs10737680 its protein levels have never been investigated in subgingival plaque samples of periodontitis patients with coronary artery disease specifically before and after non-surgical therapy. This may further improve our understanding of the influence of this polymorphism on the above mentioned systemic diseases.
Read the detailed description
Periodontitis is a chronic immuno-inflammatory disease of the gingiva and supporting tissues which is initiated and perpetuated by key periodontal pathogens that results in the destruction of periodontal supporting structures and loss of alveolar bone, eventually culminating in tooth loss. It is further influenced by the complex interaction between periodontal pathogens and the host immune response. Untreated periodontal infection may result in transient bacteremia and toxaemia which may be the cause of adverse systemic events, leading to various systemic disorders. 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.
Amongst all the systemic diseases, cardiovascular disease has been recognized as a major systemic inflammatory condition that present similarities with periodontal disease. Linking mechanisms between periodontal and cardiovascular disease include shared risk factors, increased fibrinogen, the role of white blood cells (WBC), the effect of bacterial lipopolysaccharide (LPS), and acute phase reactants such as C - reactive protein. Increased systemic biomarkers of inflammation associated with periodontal disease have been interpreted as a mechanistic link between periodontitis and cardiovascular diseases.
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 Dickkopf-3 and complement factor H polymorphisms.
Dickkopf-3 belongs to Dickkopf family of glycoproteins. This protein contains an N-terminal soggy domain and 2 conserved cysteine rich domains (CRDS) which is encoded by the Dickkopf-3 gene. These regulate the WNT signaling pathway, and other signaling cascades such as transforming growth factor beta (TGFβ) signaling. Dickkopf-3 has been mainly investigated in oncology for its role as a tumor suppressor gene and as a therapeutic target in several types of human carcinomas. Recently, Dickkopf-3 gained attention as an emerging biomarker for cardiovascular and renal diseases. Dickkopf-3 has shown to play a role in pathophysiology of arterial wall thickening and abnormality implicated in atherosclerosis. However, genetic polymorphism of Dickkopf-3 rs11544814 and its protein levels have never been investigated in patients with periodontitis with coronary artery disease. This may further improve our understanding of the influence of this polymorphism on the above mentioned systemic diseases.
Another novel polymorphism contributing to periodontitis and coronary artery disease is the complement factor H polymorphism. The complement pathway is an essential component of the innate immune system which participates in the elimination of pathogens and bridges the gap between innate and adaptive immunity. Complement factor H is a soluble complement regulator essential for controlling the alternative pathway in blood and on cell surfaces. By recognizing the host cell markers, complement factor H not only controls the complement during normal homeostasis, but also plays an important role by limiting complement mediated damage of diseased cells and tissues. Inadequate recognition of cells by complement factor H results in pathologies such as inherited atypical haemolytic uremic syndrome (aHUS), age related macular degeneration (ARMD), and membrano-proliferative glomerulonephritis type II. Recent studies reported that complement factor H polymorphism is associated with an increased risk of cardiovascular diseases in the elderly population. Studies have also been done to identify various complement factor H polymorphisms, however none of the studies have explored the role of complement factor H rs10737680 and its protein level in subjects with both periodontal disease and coronary artery disease occurring as a continuum. Its expression in periodontal tissues of cardiovascular disease patients is yet to be explored which might act as a potent health assessment tool associating periodontal and cardiovascular diseases in future.
NEED FOR THE STUDY While there are studies which have demonstrated the expression of Dickkopf-3 and complement factor H 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 artery disease which may alter following non-surgical periodontal therapy.
- Conditions
- Periodontal Diseases
- Being tested
- Non surgical periodontal therapy
- Keywords
- Periodontitis, Cardiovascular disease, Non surgical periodontal therapy, Biomarker
- Medical subject headings
- Periodontal Diseases, Periodontitis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical periodontal therapyProcedure or surgery
Also called Scaling and root planing
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 inflamed.
| Study group | Role | What they receive |
|---|---|---|
| GROUP I: 40 systemically healthy subjects with healthy periodontium. | No intervention | 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: 40 periodontitis patients without coronary artery 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: Non surgical periodontal therapy |
| GROUP III: 40 coronary artery 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: Non surgical periodontal therapy |
| GROUP IV: 40 periodontitis patients with coronary artery disease. | Experimental | Coronary artery disease (CAD) 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: Non surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periodontal parameters
Change in Periodontal Probing Depth (measured in mm higher value indicate disease progression)
Measured: Two years
Change in periodontal variables
Change in Clinical Attachment Level (measured in mm higher value indicate disease progression)
Measured: Two 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: Two years
Change in periodontal variables
Change in Gingival index (measured as a ratio, higher value indicates severity of gingival inflammation
)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 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
- NCT05828368
- Sponsor's protocol ID
- 000
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng WL, Yang Y, Zhang XJ, Guo J, Gong J, Gong FH, She ZG, Huang Z, Xia H, Li H. Dickkopf-3 Ablation Attenuates the Development of Atherosclerosis in ApoE-Deficient Mice. J Am Heart Assoc. 2017 Feb 20;6(2):e004690. doi: 10.1161/JAHA.116.004690.
PubMed 28219919
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Dickkopf-3 rs11544814 and Complement Factor H rs10737680 Genetic Polymorphism and Change in Their Protein Levels Before and After Non Surgical Periodontal Therapy in Periodontitis Patients With and Without Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05828368
- Acronym / sponsor ID
- 000
- Conditions
- Periodontal Diseases
- Keywords
- Periodontitis, Cardiovascular disease, Non surgical periodontal therapy, Biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 25 Apr 2023 (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.
Untreated periodontal infection may result in transient bacteremia and toxaemia which may be the cause of adverse systemic events, leading to various systemic disorders. Amongst all the systemic diseases, cardiovascular disease has been recognized as a major systemic inflammatory condition that present similarities with periodontal disease. Increased systemic biomarkers of inflammation associated with periodontal disease have been interpreted as a mechanistic link between periodontitis and cardiovascular diseases.
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 Dickkopf-3 and complement factor H polymorphisms.
Dickkopf-3 belongs to Dickkopf family of glycoproteins. Dickkopf-3 has been mainly investigated in oncology for its role as a tumor suppressor gene and as a therapeutic target in several types of human carcinomas. Recently, Dickkopf-3 gained attention as an emerging biomarker for cardiovascular and renal diseases. Dickkopf-3 has shown to play a role in pathophysiology of arterial wall thickening and abnormality implicated in atherosclerosis.
However, genetic polymorphism of Dickkopf-3 rs11544814 and complement factor H rs10737680 its protein levels have never been investigated in subgingival plaque samples of periodontitis patients with coronary artery disease specifically before and after non-surgical therapy. This may further improve our understanding of the influence of this polymorphism on the above mentioned systemic diseases.
Detailed description
Periodontitis is a chronic immuno-inflammatory disease of the gingiva and supporting tissues which is initiated and perpetuated by key periodontal pathogens that results in the destruction of periodontal supporting structures and loss of alveolar bone, eventually culminating in tooth loss. It is further influenced by the complex interaction between periodontal pathogens and the host immune response. Untreated periodontal infection may result in transient bacteremia and toxaemia which may be the cause of adverse systemic events, leading to various systemic disorders. 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.
Amongst all the systemic diseases, cardiovascular disease has been recognized as a major systemic inflammatory condition that present similarities with periodontal disease. Linking mechanisms between periodontal and cardiovascular disease include shared risk factors, increased fibrinogen, the role of white blood cells (WBC), the effect of bacterial lipopolysaccharide (LPS), and acute phase reactants such as C - reactive protein. Increased systemic biomarkers of inflammation associated with periodontal disease have been interpreted as a mechanistic link between periodontitis and cardiovascular diseases.
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 Dickkopf-3 and complement factor H polymorphisms.
Dickkopf-3 belongs to Dickkopf family of glycoproteins. This protein contains an N-terminal soggy domain and 2 conserved cysteine rich domains (CRDS) which is encoded by the Dickkopf-3 gene. These regulate the WNT signaling pathway, and other signaling cascades such as transforming growth factor beta (TGFβ) signaling. Dickkopf-3 has been mainly investigated in oncology for its role as a tumor suppressor gene and as a therapeutic target in several types of human carcinomas. Recently, Dickkopf-3 gained attention as an emerging biomarker for cardiovascular and renal diseases. Dickkopf-3 has shown to play a role in pathophysiology of arterial wall thickening and abnormality implicated in atherosclerosis. However, genetic polymorphism of Dickkopf-3 rs11544814 and its protein levels have never been investigated in patients with periodontitis with coronary artery disease. This may further improve our understanding of the influence of this polymorphism on the above mentioned systemic diseases.
Another novel polymorphism contributing to periodontitis and coronary artery disease is the complement factor H polymorphism. The complement pathway is an essential component of the innate immune system which participates in the elimination of pathogens and bridges the gap between innate and adaptive immunity. Complement factor H is a soluble complement regulator essential for controlling the alternative pathway in blood and on cell surfaces. By recognizing the host cell markers, complement factor H not only controls the complement during normal homeostasis, but also plays an important role by limiting complement mediated damage of diseased cells and tissues. Inadequate recognition of cells by complement factor H results in pathologies such as inherited atypical haemolytic uremic syndrome (aHUS), age related macular degeneration (ARMD), and membrano-proliferative glomerulonephritis type II. Recent studies reported that complement factor H polymorphism is associated with an increased risk of cardiovascular diseases in the elderly population. Studies have also been done to identify various complement factor H polymorphisms, however none of the studies have explored the role of complement factor H rs10737680 and its protein level in subjects with both periodontal disease and coronary artery disease occurring as a continuum. Its expression in periodontal tissues of cardiovascular disease patients is yet to be explored which might act as a potent health assessment tool associating periodontal and cardiovascular diseases in future.
NEED FOR THE STUDY While there are studies which have demonstrated the expression of Dickkopf-3 and complement factor H 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 artery disease which may alter following non-surgical periodontal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP I: 40 systemically healthy subjects with healthy periodontium. | No intervention | –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: 40 periodontitis patients without coronary artery disease | Experimental | Procedure: Non surgical periodontal therapySystemically 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: 40 coronary artery disease patients without periodontitis. | Experimental | Procedure: Non surgical periodontal therapyPatients 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: 40 periodontitis patients with coronary artery disease. | Experimental | Procedure: Non surgical periodontal therapyCoronary artery disease (CAD) 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)
- 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 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 |
|---|---|---|
| Non surgical periodontal therapyAlso: 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 inflamed. | Procedure or surgery | GROUP II: 40 periodontitis patients without coronary artery disease, GROUP III: 40 coronary artery disease patients without periodontitis., GROUP IV: 40 periodontitis patients with coronary artery disease. |
Primary outcome
Change in periodontal parameters
Time frame: Two years
Change in Periodontal Probing Depth (measured in mm higher value indicate disease progression)
Change in periodontal variables
Time frame: Two years
Change in Clinical Attachment Level (measured in mm higher value indicate disease progression)
Change in periodontal criteria
Time frame: Two 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: Two years
Change in Gingival index (measured as a ratio, higher value indicates severity of gingival inflammation )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Background: PubMed 28219919Cheng WL, Yang Y, Zhang XJ, Guo J, Gong J, Gong FH, She ZG, Huang Z, Xia H, Li H. Dickkopf-3 Ablation Attenuates the Development of Atherosclerosis in ApoE-Deficient Mice. J Am Heart Assoc. 2017 Feb 20;6(2):e004690. doi: 10.1161/JAHA.116.004690.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical periodontal therapy in people with Periodontal Diseases, 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: status not confirmed, as of the sponsor's last update on 22 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaideep Mahendra, MDS, Ph.D Post Doc(USA) (9444963973, jaideep_m_23@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in periodontal parameters (time frame: Two years). 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 NCT05828368, which also lists 1 linked publication.
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 May 2023.