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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03425383 |
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Date of registration:
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31/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Association of Endodontic Infection With Cardiovascular Disease.
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Scientific title:
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Association of Endodontic Infection With Cardiovascular Disease Via Non-invasive Assessment of Endothelial Function |
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Date of first enrolment:
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November 1, 2016 |
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Target sample size:
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120 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03425383 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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Sanjay Tewari |
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Address:
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Telephone:
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283876 |
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Email:
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principalpgids@yahoo.in |
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Affiliation:
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Name:
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NISHANT CHAUHAN |
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Address:
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Telephone:
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9991772647 |
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Email:
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catchnishu619@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Apical Periodontitis
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Intervention(s)
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Diagnostic Test: FMD and c-IMT
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Primary Outcome(s)
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Difference in FMD and c-IMT between test and control groups.
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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