Coronary Heart DiseaseNCT04127474
Expression of Trefoil Factors and Adrenomedullin in Subjects With Chronic Periodontitis and Coronary Heart Disease
An observational study of Coronary Heart Disease and Periodontal Diseases, run by Meenakshi Ammal Dental College and Hospital at 1 site in India.
Trial summary
To assess the demographic variables, periodontal parameters and to determine the expression of Trefoil factors 2 and 3 and Adrenomedullin in unstimulated saliva samples of periodontally healthy subjects with coronary heart disease and generalised chronic periodontitis subjects with and without coronary heart disease. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Periodontal Diseases
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 14 Oct 2019to 20 Nov 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants from 30 years to 65 years will be recruited for the study. Subjects would be categorized into the above mentioned three groups based on their medical status.
Who may be able to join
- Patients willing to participate in the study.
- Patients within the age group of 30-65 years.
- Patients should have ≥ 20 remaining natural teeth.
- For Group I
- Systemically healthy, Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) ≥ 2mm, radiographic evidence of alveolar crestal bone loss ≥ 2mm from the cemento-enamel junction.
- For Group II
- Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) ≥ 2mm, radiographic evidence of alveolar crestal bone loss ≥ 2mm from the cemento-enamel junction along with coronary heart disease.
- For Group III • Periodontally healthy subjects with Probing pocket depth (PD) less than 4mm, bleeding on probing (BOP) at ≤15% of tooth sites, no periodontal treatment (Scaling and root planing or periodontal surgery) within the previous 6 months and without evident clinical signs of gingival inflammation along with the presence of coronary heart disease.
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 and HIV infection will be excluded from the present investigation.
- For Group I, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
- Current smokers and individuals who quit smoking less than 6 months.
- Patients who have undergone periodontal therapy within the previous 6 months.
- Pregnant women (pregnancy may alter the oral flora)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Meenakshi Ammal Dental College
Chennai, Tamil Nadu, 600095
Jaideep Mahendra, MDS, PhD, 9444963973, jaideep_m_23@yahoo.co.in
Sruthi Srinivasan, BDS, 9962152960, sruthi22596@gmail.com
About this study
Official title: Expression of Trefoil Factors 2 and 3 and Adrenomedullin in Unstimulated Saliva Samples of Chronic Periodontitis Subjects With and Without Coronary Heart Disease
To assess the demographic variables, periodontal parameters and to determine the expression of Trefoil factors 2 and 3 and Adrenomedullin in unstimulated saliva samples of periodontally healthy subjects with coronary heart disease and generalised chronic periodontitis subjects with and without coronary heart disease.
Read the detailed description
A total of 75 subjects will be recruited for the study based on the power of the study.
The selected subjects will be divided into 3 groups based on inclusion and exclusion criteria.
GROUP I:25Generalized chronic periodontitis subjects without coronary heart disease.
GROUP II: 25Generalized chronic periodontitis subjects diagnosed with coronary heart disease.
GROUP III: 25Periodontally healthy subjects diagnosed with coronary heart disease.
Demographic variables, periodontal parameters and biochemical parameters will be measured in all three groups
- Conditions
- Coronary Heart Disease, Periodontal Diseases
- Keywords
- periodontitis, saliva, trefoil factor, adrenomedullin, Coronary heart disease
- Medical subject headings
- Coronary Disease, Periodontal Diseases, 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 | 25 Generalized chronic periodontitis subjects without coronary heart disease. | |
| Group II | 25 Generalized chronic periodontitis subjects diagnosed with coronary heart disease. | |
| Group III | 25 Periodontally healthy subjects diagnosed with coronary heart disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trefoil factors 2 and 3 and Adrenomedullin expression in Chronic periodontitis patients with and without coronary heart disease
Expression of Trefoil factors 2 and 3 and Adrenomedullin using Enzyme Linked Immunosorbent Assay
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start14 Oct 2019
- Primary completion20 Dec 2020 (estimated)
- Study completion20 Nov 2021 (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 Coronary Heart DiseaseStudies 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 (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
- Investigators
- Jaideep Mahendra, MDS, PhD, Study director, Meenakshi Ammal Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127474
- Sponsor's protocol ID
- MADC/IRB-XXIX/2019/468
- Status last verified
- Sep 2020
- First submitted
- 14 Oct 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.
PubMed 22181686Suchetha A, Garg A, Lakshmi P, Bhat D, Sapna N, Apoorva SM. Adrenomedullin, periodontitis, diabetes-unraveling the equivocal relationship: A clinicobiochemical cross-sectional study. Contemp Clin Dent. 2013 Oct;4(4):454-9. doi: 10.4103/0976-237X.123040.
PubMed 24403788
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Trefoil Factors 2 and 3 and Adrenomedullin in Unstimulated Saliva Samples of Chronic Periodontitis Subjects With and Without Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT04127474
- Acronym / sponsor ID
- MADC/IRB-XXIX/2019/468
- Conditions
- Coronary Heart Disease, Periodontal Diseases
- Keywords
- periodontitis, saliva, trefoil factor, adrenomedullin, Coronary heart disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 15 Oct 2019 (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.
To assess the demographic variables, periodontal parameters and to determine the expression of Trefoil factors 2 and 3 and Adrenomedullin in unstimulated saliva samples of periodontally healthy subjects with coronary heart disease and generalised chronic periodontitis subjects with and without coronary heart disease.
Detailed description
A total of 75 subjects will be recruited for the study based on the power of the study.
The selected subjects will be divided into 3 groups based on inclusion and exclusion criteria.
GROUP I:25Generalized chronic periodontitis subjects without coronary heart disease.
GROUP II: 25Generalized chronic periodontitis subjects diagnosed with coronary heart disease.
GROUP III: 25Periodontally healthy subjects diagnosed with coronary heart disease.
Demographic variables, periodontal parameters and biochemical parameters will be measured in all three groups
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –25 Generalized chronic periodontitis subjects without coronary heart disease. |
| Group II | – | –25 Generalized chronic periodontitis subjects diagnosed with coronary heart disease. |
| Group III | – | –25 Periodontally healthy subjects diagnosed with coronary heart disease. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from 30 years to 65 years will be recruited for the study. Subjects would be categorized into the above mentioned three groups based on their medical status.
Key inclusion criteria (8 listed)
- Patients willing to participate in the study.
- Patients within the age group of 30-65 years.
- Patients should have ≥ 20 remaining natural teeth.
- For Group I
- For Group II
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 and HIV infection will be excluded from the present investigation.
- For Group I, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
- Current smokers and individuals who quit smoking less than 6 months.
- Patients who have undergone periodontal therapy within the previous 6 months.
- Pregnant women (pregnancy 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
Trefoil factors 2 and 3 and Adrenomedullin expression in Chronic periodontitis patients with and without coronary heart disease
Time frame: 12 months
Expression of Trefoil factors 2 and 3 and Adrenomedullin using Enzyme Linked Immunosorbent Assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Background: PubMed 22181686Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.
- Background: PubMed 24403788Suchetha A, Garg A, Lakshmi P, Bhat D, Sapna N, Apoorva SM. Adrenomedullin, periodontitis, diabetes-unraveling the equivocal relationship: A clinicobiochemical cross-sectional study. Contemp Clin Dent. 2013 Oct;4(4):454-9. doi: 10.4103/0976-237X.123040.
- 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 Coronary Heart Disease and Periodontal Diseases, 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 8 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 2 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaideep Mahendra, MDS, PhD (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?
Trefoil factors 2 and 3 and Adrenomedullin expression in Chronic periodontitis patients with and without coronary heart disease (time frame: 12 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 NCT04127474, 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 2 Sep 2020.