Periodontal DiseasesNCT03721159
Quantification of Micro-RNA 146-a in Chronic Periodontitis and Coronary Heart Disease Subjects
An observational study of Periodontal Diseases and Coronary Disease, run by Meenakshi Ammal Dental College and Hospital at 1 site in India.
Trial summary
The expression and quantification of Micro-RNA 146-a, was analyzed in the subgingival plaque samples of generalized chronic periodontitis patients with and without coronary heart disease. The demographic variables and periodontal parameters were assessed and correlated with expression of micro-RNA 146-a. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Coronary Disease
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2017to 1 Oct 2018
- 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 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All male patients within the age group of 35-65 years. The subjects were from South Indian population.
Who may be able to join
- Patients willing to participate in the study.
- Patients within the age group of 35-65 years.
- Should have ≥ 10 natural teeth.
- For group I Generalized chronic periodontitis patients with coronary heart disease: Generalised chronic periodontitis is defined as those having 30% or more sites with clinical attachment loss (CAL) ≥ 3mm.
- For group II Generalized chronic periodontitis patients without coronary heart disease.
- Healthy controls were selected based on the following criteria: Probing pocket depth (PD) less than 4mm, bleeding on probing (BOP) at ≤15% of tooth sides, and no periodontal treatment (Scaling and root planning or periodontal surgery) within the previous six months.
Who cannot join
- Patients with systemic conditions such as type I, type II and pre diabetes mellitus, respiratory diseases, renal disease, liver disease, collagenosis, rheumatoid arthritis, allergy, advanced malignancies and HIV infection were excluded from the present investigation.
- Use of drugs such as corticosteroids, antibiotics within 6 month of investigation and immuno-suppressive chemotherapy.
- Smokers and other behavioural factors which may influence the study.
- Patients who had undergone periodontal therapy within the previous 6 months.
- Female patients (due to hormonal changes and pregnancy which may alter the oral flora).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Micro-RNA (miRNA)146-a in Subgingival Plaque Samples of Generalized Chronic Periodontitis Patients With and Without Coronary Heart Disease.
The expression and quantification of Micro-RNA 146-a, was analyzed in the subgingival plaque samples of generalized chronic periodontitis patients with and without coronary heart disease. The demographic variables and periodontal parameters were assessed and correlated with expression of micro-RNA 146-a. The quantification of levels of micro-RNA 146-a was done using Real time Polymerase chain reaction. ( RT-PCR)
Read the detailed description
The quantification of the levels of MicroRNA 146-a was analyzed in subgingival plaque samples of generalized chronic periodontitis subjects with and without coronary heart disease and compared them with the healthy subject.A total of 90 subjects were selected for the study and assigned to 3 groups based on inclusion and exclusion criteria. Group I comprised of 30 subjects with Generalized chronic periodontitis diagnosed with coronary heart disease.Group II comprised of 30 subjects with Generalized chronic periodontitis without coronary heart disease and Group III comprised of 30 systemically healthy volunteers with no chronic periodontitis or coronary heart disease. Demographic variables such as age, weight,height,BMI and income and clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachement levels were recorded. Subgingival plaque samples were collected from all the 3 groups. The collected samples were subject to further molecular analysis for micro-RNA expression and quantification using RT-PCR.
- Conditions
- Periodontal Diseases, Coronary Disease
- Keywords
- Micro-RNA, Chronic periodontitis
- Medical subject headings
- Periodontal Diseases, Coronary Disease, Chronic Periodontitis
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 |
|---|---|---|
| Group I | 30 Generalized chronic periodontitis subjects diagnosed with Coronary heart disease. | |
| Group II | 30 Generalized chronic periodontitis subjects without coronary heart disease. | |
| Group III | 30 Systemically healthy patients with no chronic periodontitis or coronary heart disease. |
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
Expression of Micro-RNA 146-a using real time PCR
Measured: 9 months
Secondary outcomes (1)
Levels of Micro-RNA 146-a in chronic periodontitis patients with and without coronary heart disease
Levels of Micro-RNA 146-a using real time PCR
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Oct 2017
- Primary completion1 Sep 2018
- Study completion1 Oct 2018
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 90 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
- Investigators
- Jaideep Mahendra, MDS,PhD, Study director, Meenakshi Ammal Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721159
- Sponsor's protocol ID
- MADC/IRB-XI/2017/225
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie YF, Shu R, Jiang SY, Liu DL, Zhang XL. Comparison of microRNA profiles of human periodontal diseased and healthy gingival tissues. Int J Oral Sci. 2011 Jul;3(3):125-34. doi: 10.4248/IJOS11046.
PubMed 21789961
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Micro-RNA (miRNA)146-a in Subgingival Plaque Samples of Generalized Chronic Periodontitis Patients With and Without Coronary Heart Disease.
- ClinicalTrials.gov ID
- NCT03721159
- Acronym / sponsor ID
- MADC/IRB-XI/2017/225
- Conditions
- Periodontal Diseases, Coronary Disease
- Keywords
- Micro-RNA, Chronic periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 26 Oct 2018 (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 expression and quantification of Micro-RNA 146-a, was analyzed in the subgingival plaque samples of generalized chronic periodontitis patients with and without coronary heart disease. The demographic variables and periodontal parameters were assessed and correlated with expression of micro-RNA 146-a. The quantification of levels of micro-RNA 146-a was done using Real time Polymerase chain reaction. ( RT-PCR)
Detailed description
The quantification of the levels of MicroRNA 146-a was analyzed in subgingival plaque samples of generalized chronic periodontitis subjects with and without coronary heart disease and compared them with the healthy subject.A total of 90 subjects were selected for the study and assigned to 3 groups based on inclusion and exclusion criteria. Group I comprised of 30 subjects with Generalized chronic periodontitis diagnosed with coronary heart disease.Group II comprised of 30 subjects with Generalized chronic periodontitis without coronary heart disease and Group III comprised of 30 systemically healthy volunteers with no chronic periodontitis or coronary heart disease. Demographic variables such as age, weight,height,BMI and income and clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachement levels were recorded. Subgingival plaque samples were collected from all the 3 groups. The collected samples were subject to further molecular analysis for micro-RNA expression and quantification using RT-PCR.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –30 Generalized chronic periodontitis subjects diagnosed with Coronary heart disease. |
| Group II | – | –30 Generalized chronic periodontitis subjects without coronary heart disease. |
| Group III | – | –30 Systemically healthy patients with no chronic periodontitis or coronary heart disease. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All male patients within the age group of 35-65 years. The subjects were from South Indian population.
Key inclusion criteria (6 listed)
- Patients willing to participate in the study.
- Patients within the age group of 35-65 years.
- Should have ≥ 10 natural teeth.
- For group I Generalized chronic periodontitis patients with coronary heart disease: Generalised chronic periodontitis is defined as those having 30% or more sites with clinical attachment loss (CAL) ≥ 3mm.
- For group II Generalized chronic periodontitis patients without coronary heart disease.
Key exclusion criteria (5 listed)
- Patients with systemic conditions such as type I, type II and pre diabetes mellitus, respiratory diseases, renal disease, liver disease, collagenosis, rheumatoid arthritis, allergy, advanced malignancies and HIV infection were excluded from the present investigation.
- Use of drugs such as corticosteroids, antibiotics within 6 month of investigation and immuno-suppressive chemotherapy.
- Smokers and other behavioural factors which may influence the study.
- Patients who had undergone periodontal therapy within the previous 6 months.
- Female patients (due to hormonal changes and pregnancy which may alter the oral flora).
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: 9 months
Expression of Micro-RNA 146-a using real time PCR
1 secondary outcome
Levels of Micro-RNA 146-a in chronic periodontitis patients with and without coronary heart disease
Time frame: 9 months
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 26 Oct 2018.
- Background: PubMed 21789961Xie YF, Shu R, Jiang SY, Liu DL, Zhang XL. Comparison of microRNA profiles of human periodontal diseased and healthy gingival tissues. Int J Oral Sci. 2011 Jul;3(3):125-34. doi: 10.4248/IJOS11046.
- 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.
Jaideep Mahendra, MDS,PhD study director
Meenakshi Ammal Dental College
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 Periodontal Diseases and Coronary 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 6 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 26 Oct 2018. 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: 9 months). 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 NCT03721159, 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 26 Oct 2018.