Influence of Periodontal Diseases on Vascular Parameters... | NCT02394860

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

NCT02394860

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Aug 3, 2025Actual

Enrollment

76Actual

Phase

Not provided

Conditions

Chronic Periodontitis
Hypertension

Interventions

echo Doppler lower limbs

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no patient

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Feb 2024Actual

Completion Date

Feb 2024Actual

First Submitted Date

Jul 8, 2014

First Submission Date that Met QC Criteria

Mar 16, 2015

First Posted Date

Mar 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2025

Last Update Posted Date

Aug 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Label	Type	Description	Intervention Names
blood and cardiological examination			Other: echo Doppler lower limbs

Name	Type	Description	Arm Group Labels	Other Names
echo Doppler lower limbs	Other		blood and cardiological examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measuring the thickness of the intima-media		15 days

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of anatomical changes that may occur at the arterial level		Within 15 days after inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Will be included men with severe and moderate periodontitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier HUCK, MD	CHRU Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de parodontologie		Strasbourg		67000	France

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis
D006973	Hypertension

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided