NCT04127487

Brief Summary

Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) will be analysed in the subgingival plaque and blood samples of generalized chronic periodontitis with and without coronary heart disease. The demographic and the periodontal parameters were assessed and correlated with the quantification of NLRP3 (rs4612666) and CARD8 (rs2043211) was analysed with RT-PCR

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
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

October 14, 2019

Last Update Submit

December 1, 2019

Conditions

Periodontal DiseasesCoronary Artery Disease

Keywords

NLRP3 (rs4612666), CARD8 (rs20432111)

Outcome Measures

Primary Outcomes (1)

  • Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene

    Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR

    12 months

Secondary Outcomes (1)

  • Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene

    12 months

Study Arms (2)

Periodontitis group

35 Generalized chronic periodontitis subjects without coronary heart diseases

periodontitis with CAD group

35 Generalized chronic periodontitis subjects diagnosed with Coronary heart disease

Eligibility Criteria

Age30 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male patients in the age group of 30-65 years were included. Females were excluded due to hormonal changes or pregnancy that may alter the oral flora
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All male patients within the age group of 30-65 years. The subjects were from south indian population

You may qualify if:

  • Patients willing to participate in the study
  • Patients within the age group of 30-65 years ( male )
  • Patients should have ≥ 20 remaining natural teeth
  • No history of long term antibiotic use in the past 6 months
  • For group I generalized chronic periodontitis patients with coronary heart disease
  • For group II generalized chronic periodontitis patients without coronary heart disease

You may not qualify if:

  • Patients 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.
  • Patients on drugs such as corticosteroids, antibiotics within 3 months of investigation will be excluded.
  • Current smokers, individuals who quit smoking less than 6 months ago.
  • Patients who had undergone periodontal therapy within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaideep Mahendra

Chennai, Tamil Nadu, 600095, India

RECRUITING

Related Publications (1)

  • Isaza-Guzman DM, Hernandez-Viana M, Bonilla-Leon DM, Hurtado-Cadavid MC, Tobon-Arroyave SI. Determination of NLRP3 (rs4612666) and IL-1B (rs1143634) genetic polymorphisms in periodontally diseased and healthy subjects. Arch Oral Biol. 2016 May;65:44-51. doi: 10.1016/j.archoralbio.2016.01.013. Epub 2016 Jan 27.

    PMID: 26854620BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jaideep Mahendra, MDS, PhD

    Meenakshi Ammal Dental College

    STUDY DIRECTOR

Central Study Contacts

Jaideep Mahendra, MDS, PhD

CONTACT

9444963973jaideep_m_23@yahoo.co.in

Abirami Nayaki Rao, BDS

CONTACT

9176327362abirami.nayaki1791@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and PhD guide

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 15, 2019

Study Start

October 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)