NCT02394860

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

8.8 years

First QC Date

July 8, 2014

Last Update Submit

August 1, 2025

Conditions

Chronic PeriodontitisHypertension

Outcome Measures

Primary Outcomes (1)

  • Measuring the thickness of the intima-media

    15 days

Secondary Outcomes (1)

  • Evaluation of anatomical changes that may occur at the arterial level

    Within 15 days after inclusion

Study Arms (1)

blood and cardiological examination

Other: echo Doppler lower limbs

Interventions

echo Doppler lower limbsOTHER
blood and cardiological examination

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Will be included men with severe and moderate periodontitis

You may qualify if:

  • Men- \>40 years
  • moderate and severe generalized chronic periodontitis
  • Former diagnosis of hypertension
  • \>12 teeth

You may not qualify if:

  • \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de parodontologie

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Chronic PeriodontitisHypertension

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Olivier HUCK, MD

    CHRU Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

March 20, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

August 3, 2025

Record last verified: 2025-08

Locations

FR(1)