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

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02394860
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Anticipated Duration (Months): 100
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	Phase
Chronic Periodontitis; Hypertension	Other: echo Doppler lower limbs

Study Design

• Study Type: Observational
• Anticipated 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: Apr 1, 2015
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
blood and cardiological examination	Other: echo Doppler lower limbs

Outcome Measures

Primary Outcome Measures

1. Measuring the thickness of the intima-media [15 days]

Secondary Outcome Measures

1. Evaluation of anatomical changes that may occur at the arterial level [Within 15 days after inclusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de parodontologie	Strasbourg		France	67000

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Olivier HUCK, MD, CHRU Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT02394860
• Other Study ID Numbers: 5883
• First Posted: Mar 20, 2015
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis; Periodontal Diseases; Chronic Periodontitis; Hypertension

Study Results

No Results Posted as of Aug 19, 2022