- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02394860
Influence of Periodontal Diseases on Vascular Parameters in Patients Suffering of Hypertension
February 16, 2024 updated by: University Hospital, Strasbourg, France
Influence of Periodontal Diseases on Hemodynamic and Molecular Vascular Parameters in Patients Suffering of Hypertension
The aim of this study is to assess the influence of the severity of chronic periodontitis on hemodynamic parameters in hypertensive patients.Secondary purposes of this protocol is to identify evolution of several biomarkers and correlate the clinical situation with oral microflora.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sanchez Dimitri
- Email: drci@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67000
- Service de parodontologie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Will be included men with severe and moderate periodontitis
Description
Inclusion Criteria:
- -Men- >40 years
- moderate and severe generalized chronic periodontitis
- Former diagnosis of hypertension
- >12 teeth
Exclusion Criteria:
- >70 years
- smokers (>10 cig/day)
- body mass index>30
- Need of antibioprophylaxis
- Medical treatment including anti-inflammatory drugs and/or antibiotics
- Refractory form of hypertension- aggressive periodontitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
blood and cardiological examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measuring the thickness of the intima-media
Time Frame: 15 days
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of anatomical changes that may occur at the arterial level
Time Frame: Within 15 days after inclusion
|
Within 15 days after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Olivier HUCK, MD, CHRU Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
July 8, 2014
First Submitted That Met QC Criteria
March 16, 2015
First Posted (Estimated)
March 20, 2015
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5883
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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