NCT03425383

Brief Summary

Chronic inflammation plays a crucial role in the genesis of atherosclerosis and at the same time promotes acute cardiovascular events. Periodontal and pulpal inflammation are two major low grade chronic inflammatory infectious disease of oral cavity. Apical periodontitis is an inflammatory process, most often chronic in nature, of endodontic origin usually occurring at or near apex of the tooth root. The scientific literature has failed to provide the potential connection between endodontic infection and CV risk. Few studies have found the possible association, yet few studies does not suggest any link. The association between chronic inflammatory lesions and endothelial dysfunction can be detected using inflammatory, invasive and non-invasive markers. Inflammatory markers such as hs-CRP and Interleukins are not cost efficient and invasive markers- Angiography and Plethysmography are unethical to use on asymptomatic subjects. Non-invasive markers such as Flow mediated dilatation (FMD) and carotid intima media thickness (c-IMT) are inexpensive, fast and safe. The rationale of our study is to check the possible association between endodontic infection and CVD using non-invasive markers.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

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 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

February 7, 2018

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

January 31, 2018

Last Update Submit

February 6, 2018

Conditions

Apical Periodontitis

Keywords

Cardiovascular disease, FMD, c-IMT

Outcome Measures

Primary Outcomes (1)

  • Difference in FMD and c-IMT between test and control groups.

    The primary outcome variables observed for the study will be the difference in the FMD and c-IMT of the test group and control group.

    1 year

Study Arms (2)

Test group

Subjects having periapical disease diagnosed clinically and radiographically and free from any other systemic illness. FMD and c-IMT will be determined by ultrasound

Diagnostic Test: FMD and c-IMT

Control group

Healthy subject. FMD and c-IMT will be determined by ultrasound

Diagnostic Test: FMD and c-IMT

Interventions

FMD and c-IMTDIAGNOSTIC_TEST

The diameter of the target artery (right brachial artery) will be measured from two- dimensional ultrasound images, with a 70 MHz linear array transducer and a standard 128XP/10 system (Acuson, Mountain View, California, USA). c-IMT will be assessed by M-mode ultrasonography via a vivid 7 MHz linear array transducer and a standard 128XP/10 system (Acuson, Mountain View, California, USA) with participants in the supine position.

Control groupTest group

Eligibility Criteria

Age20 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales between 20-40 years of age
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study subjects will be obtained from the pool of OPD patients in the Department of Conservative dentistry and Endodontics, PGIDS, Rohtak.

You may qualify if:

  • years of Male.
  • Presence of apical periodontitis as assessed both clinically and radiographically (teeth with apical symptoms but without radiographic appearance of AP were not include).
  • Presence of at least 25 teeth.
  • Echocardiographic Left Ventricle Ejection Fraction (LVEF) value \>55%.
  • Hepatic and renal function within normal limits (bilirubin\<1.5mg/dl; creatine\<2.0mg/dl).

You may not qualify if:

  • Presence of localized or diffuse periodontal disease.
  • Presence of non-endodontic lesion in Maxilla/ mandible.
  • Presence of cardiovascular risk factors(arterial hypertension, dyslipidemia, DM, obesity, smoking)
  • LV hypertrophy at echocardiography previous or current CVD.
  • Presence of chronic inflammatory conditions in other regions involving systemic health.
  • For women, use of anticonceptive hormones.
  • Systemic antibiotic treatment within the previous 3 months or any other regular medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Periapical PeriodontitisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Central Study Contacts

NISHANT CHAUHAN

CONTACT

9991772647catchnishu619@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 7, 2018

Study Start

November 1, 2016

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

February 7, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)