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Influence of Periodontal Diseases on Vascular Parameters in Patients Suffering of Hypertension

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ClinicalTrials.gov Identifier: NCT02394860
Recruitment Status : Recruiting
First Posted : March 20, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Periodontitis Hypertension Other: echo Doppler lower limbs

Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Periodontal Diseases on Hemodynamic and Molecular Vascular Parameters in Patients Suffering of Hypertension
Actual Study Start Date : April 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease

Group/Cohort Intervention/treatment
blood and cardiological examination Other: echo Doppler lower limbs



Primary Outcome Measures :
  1. Measuring the thickness of the intima-media [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Evaluation of anatomical changes that may occur at the arterial level [ Time Frame: Within 15 days after inclusion ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Will be included men with severe and moderate periodontitis
Criteria

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

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): NCT02394860


Contacts
Contact: Sanchez Dimitri drci@chru-strasbourg.fr

Locations
France
Service de parodontologie Recruiting
Strasbourg, France, 67000
Contact: Olivier Huck, MD       olivier.huck@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Olivier HUCK, MD CHRU Strasbourg

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02394860     History of Changes
Other Study ID Numbers: 5883
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Gingival Diseases
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases