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Trial record 6 of 86 for:    Recruiting, Not yet recruiting, Available Studies | "Jaw Diseases"

Association of Endodontic Infection With Cardiovascular Disease.

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ClinicalTrials.gov Identifier: NCT03425383
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

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.

Condition or disease Intervention/treatment
Apical Periodontitis Diagnostic Test: FMD and c-IMT

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Association of Endodontic Infection With Cardiovascular Disease Via Non-invasive Assessment of Endothelial Function
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : March 30, 2018

Group/Cohort Intervention/treatment
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

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 group
Healthy subject. FMD and c-IMT will be determined by ultrasound
Diagnostic Test: FMD and c-IMT

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.





Primary Outcome Measures :
  1. Difference in FMD and c-IMT between test and control groups. [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males between 20-40 years of age
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 20-40 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425383


Contacts
Contact: NISHANT CHAUHAN 9991772647 catchnishu619@gmail.com

Locations
India
Post Graduate Institute of Dental Sciences Recruiting
Rohtak, Haryana, India, 124001
Contact: Sanjay Tewari    283876 ext 01262    principalpgids@yahoo.in   
Sponsors and Collaborators
Postgraduate Institute of Dental Sciences Rohtak

Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT03425383     History of Changes
Other Study ID Numbers: Nishant
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Postgraduate Institute of Dental Sciences Rohtak:
Cardiovascular disease, FMD, c-IMT

Additional relevant MeSH terms:
Cardiovascular Diseases
Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases