Interplay of miRNA-146a and miRNA-126 in Chronic Periodon... | NCT04583085

Studies
Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease

NCT04583085

Sponsor

Meenakshi Ammal Dental College and Hospital

Status

Completed

Last Update Posted

Oct 14, 2020Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Chronic Periodontitis
Coronary Artery Disease
miRNA

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Oct 3, 2020

First Submission Date that Met QC Criteria

Oct 8, 2020

First Posted Date

Oct 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2020

Last Update Posted Date

Oct 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr.Jaideep Mahendra, Professor, Director of PG education, Meenakshi Ammal Dental College and HospitalPrincipal Investigator

Lead Sponsor

Meenakshi Ammal Dental College and HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 chronic periodontitis with and without coronary artery disease.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients volunteering for the investigation.
Patients between the age group of 30-70 years
Presence of ≥ 15 natural teeth.

Exclusion criteria:

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only male patients in the age group of 30-70 years were included. Females were excluded due to hormonal changes or pregnancy that may alter the oral flora

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Male subjects within 30-70 years of age were selected for the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meenakshi Ammal Dental college		Chennai	Tamil Nadu	600095	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

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Browse Branches

Not provided