NCT04172870

Brief Summary

To assess and compare the demographic variables, periodontal parameters, cardiac parameters and the expression of periodontal viruses (CMV, HSV and EBV) and inflammatory biomarkers(PTX-3, TLR-2 \& TLR-4) in periodontally healthy and generalized periodontitis patients with and without coronary artery disease(CAD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

November 20, 2019

Last Update Submit

February 19, 2020

Conditions

PeriodontitisCoronary Artery Disease

Keywords

Ebstein Barr VirusCytomegalovirusHerpes Simplex VirusPentraxinsToll Like Receptors

Outcome Measures

Primary Outcomes (1)

  • Periodontal Virus and Inflammatory Markers expression in periodontitis patients with coronary artery disease

    Expression of EBV, CMV, HSV, Pentraxins, TLR 2 and TLR 4 using PCR

    2 years

Study Arms (4)

Group I

Healthy group ( No generalised periodontitis and no CAD)

Diagnostic Test: Molecular analysis

Group II

Generalised periodontitis patients without CAD

Diagnostic Test: Molecular analysis

Group III

CAD patients without generalised periodontitis

Diagnostic Test: Molecular analysis

Group IV

Generalised periodontitis with CAD

Diagnostic Test: Molecular analysis

Interventions

Molecular analysisDIAGNOSTIC_TEST

RT- PCR

Group IGroup IIGroup IIIGroup IV

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Indian Population

You may qualify if:

  • Patients willing to participate in the study.
  • Patients with 30 to 65 years of age group
  • Both genders
  • Patients should have minimum of 10 natural teeth.
  • In case of group III and IV patients with coronary heart disease to be included.

You may not qualify if:

  • Patients who had undergone periodontal therapy within the previous 6 months.
  • Type I and II Diabetes mellitus
  • Sarcoidosis patients.
  • Carcinoma patients.
  • Rheumatic arthritis patients.
  • Tuberculosis patients.
  • Immunosuppressive conditions.
  • Patients with other inflammatory diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MeenakshiAmmal Dental College and Hospital

Chennai, Tamil Nadu, 600095, India

Location

Related Publications (3)

  • Gurses KM, Kocyigit D, Yalcin MU, Canpinar H, Oto MA, Ozer N, Tokgozoglu L, Guc D, Aytemir K. Enhanced Platelet Toll-like Receptor 2 and 4 Expression in Acute Coronary Syndrome and Stable Angina Pectoris. Am J Cardiol. 2015 Dec 1;116(11):1666-71. doi: 10.1016/j.amjcard.2015.08.048. Epub 2015 Sep 11.

    PMID: 26455385BACKGROUND

  • Jenny NS, Arnold AM, Kuller LH, Tracy RP, Psaty BM. Associations of pentraxin 3 with cardiovascular disease and all-cause death: the Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 2009 Apr;29(4):594-9. doi: 10.1161/ATVBAHA.108.178947. Epub 2009 Jan 22.

    PMID: 19164811BACKGROUND

  • Imbronito AV, Marcelino SL, Grande SR, Nunes FD, Romito GA. Detection of human cytomegalovirus and epstein-barr virus in coronary atherosclerotic tissue. Braz J Microbiol. 2010 Jul;41(3):563-6. doi: 10.1590/S1517-83822010000300004. Epub 2010 Sep 1.

    PMID: 24031529BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Subgingival plaque sample, Atherosclerotic plaque samples

MeSH Terms

Conditions

PeriodontitisCoronary Artery DiseaseHerpes Simplex

Interventions

Cytogenetic Analysis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic Techniques

Study Officials

  • Jaideep Mahendra, PhD

    MeenakshiAmmal Dental College & Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director of PG studies

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 21, 2019

Study Start

November 15, 2018

Primary Completion

July 1, 2020

Study Completion

December 1, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Perio-Continuum link could be shared through publications

Locations

IN(1)