Chronic PeriodontitisNCT04583085
Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease
An observational study of Chronic Periodontitis and Coronary Artery Disease, run by Meenakshi Ammal Dental College and Hospital at 1 site in India.
Trial summary
The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with… Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Chronic Periodontitis, Coronary Artery Disease, miRNA
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2018to 31 Dec 2019
- 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 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male subjects within 30-70 years of age were selected for the study
Who may be able to join
- Patients volunteering for the investigation.
- Patients between the age group of 30-70 years
- Presence of ≥ 15 natural teeth.
Who cannot join
- Patients associated with systemic diseases such as lung disorders, renal disease, liver disease, type I, type II-diabetes mellitus, HIV infection, rheumatoid arthritis, allergy or any malignancy.
- Under treatment with antibiotics, immunosuppressive drugs such as corticosteroids, within 6 months.
- Pregnant women and female patients were excluded because of the altered oral flora due to hormonal changes
- Smoking and other tobacco usage habits
- Patients who underwent periodontal treatment within 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with chronic periodontitis with and without coronary artery disease.
Read the detailed description
The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with chronic periodontitis with and without coronary artery disease.
Seventy-five participants were selected and grouped into 3 categories; 25 patients diagnosed with chronic periodontitis and coronary artery disease: CP + CAD group; 25 patients diagnosed with chronic periodontitis alone: CP group; and 25 systemically and periodontally healthy controls (HP). Demographic variables, periodontal parameters, cardiac parameters, blood pressure were obtained. miRNA-146a and miRNA126 levels were assessed in subgingival plaque (SP) samples from all the three groups. Within CP+CAD group, SP samples of CP+CADa were compared with coronary plaques samples (CP) of CP+CADb while the patient underwent CABG.
- Conditions
- Chronic Periodontitis, Coronary Artery Disease, miRNA
- Keywords
- Chronic Periodontitis, coronary artery disease, microRNA 146a, microRNA 126, plaque samples, biomarkers
- Medical subject headings
- Chronic Periodontitis, Coronary Artery Disease
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 |
|---|---|---|
| CP + CHD group | This was further divided into CP + CHDa (Subgingival plaque) and CP + CHDb (Coronary plaque) based on the nature of plaque collected. | |
| CP group | 25 patients with chronic periodontitis who were systemically healthy were selected | |
| HP group | 25 patients who were systemically and periodontally healthy, were considered as HP group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
micro-RNA 146-a expression in Chronic periodontitis patients with and without coronary heart disease.
microRNA 146-a expression was present in the chronic periodontitis subjects with coronary heart disease
Measured: 10 months
Levels of micro-RNA 126 in chronic periodontitis patients with and without coronary heart disease
microRNA 126 expression was present in chronic periodontitis subjects with coronary heart disease
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Nov 2018
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 75 participants (actual)
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
- NCT04583085
- Sponsor's protocol ID
- MADC/IRB-XXVI/2018/415
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2020
- Last updated
- 14 Oct 2020
- 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 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04583085
- Acronym / sponsor ID
- MADC/IRB-XXVI/2018/415
- Conditions
- Chronic Periodontitis, Coronary Artery Disease, miRNA
- Keywords
- Chronic Periodontitis, coronary artery disease, microRNA 146a, microRNA 126, plaque samples, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Oct 2020 (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 role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with chronic periodontitis with and without coronary artery disease.
Detailed description
The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with chronic periodontitis with and without coronary artery disease.
Seventy-five participants were selected and grouped into 3 categories; 25 patients diagnosed with chronic periodontitis and coronary artery disease: CP + CAD group; 25 patients diagnosed with chronic periodontitis alone: CP group; and 25 systemically and periodontally healthy controls (HP). Demographic variables, periodontal parameters, cardiac parameters, blood pressure were obtained. miRNA-146a and miRNA126 levels were assessed in subgingival plaque (SP) samples from all the three groups. Within CP+CAD group, SP samples of CP+CADa were compared with coronary plaques samples (CP) of CP+CADb while the patient underwent CABG.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CP + CHD group | – | –This was further divided into CP + CHDa (Subgingival plaque) and CP + CHDb (Coronary plaque) based on the nature of plaque collected. |
| CP group | – | –25 patients with chronic periodontitis who were systemically healthy were selected |
| HP group | – | –25 patients who were systemically and periodontally healthy, were considered as HP group. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male subjects within 30-70 years of age were selected for the study
Key inclusion criteria (3 listed)
- Patients volunteering for the investigation.
- Patients between the age group of 30-70 years
- Presence of ≥ 15 natural teeth.
Key exclusion criteria (5 listed)
- Patients associated with systemic diseases such as lung disorders, renal disease, liver disease, type I, type II-diabetes mellitus, HIV infection, rheumatoid arthritis, allergy or any malignancy.
- Under treatment with antibiotics, immunosuppressive drugs such as corticosteroids, within 6 months.
- Pregnant women and female patients were excluded because of the altered oral flora due to hormonal changes
- Smoking and other tobacco usage habits
- Patients who underwent periodontal treatment within 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
micro-RNA 146-a expression in Chronic periodontitis patients with and without coronary heart disease.
Time frame: 10 months
microRNA 146-a expression was present in the chronic periodontitis subjects with coronary heart disease
Levels of micro-RNA 126 in chronic periodontitis patients with and without coronary heart disease
Time frame: 10 months
microRNA 126 expression was present in chronic periodontitis subjects with coronary heart disease
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 2020.
- 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 Chronic Periodontitis and Coronary Artery Disease, run by Meenakshi Ammal Dental College and Hospital at 1 site 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 3 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: finished, as of the sponsor's last update on 14 Oct 2020. 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 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?
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?
micro-RNA 146-a expression in Chronic periodontitis patients with and without coronary heart disease. (time frame: 10 months). The study lists 2 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 2020.