Chronic PeriodontitisNCT02394860
Influence of Periodontal Diseases on Vascular Parameters in Patients Suffering of Hypertension
An observational study of Chronic Periodontitis and Hypertension, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Chronic Periodontitis, Hypertension
- What is being tested?
- echo Doppler lower limbs
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Will be included men with severe and moderate periodontitis
Who may be able to join
- -Men- >40 years
- moderate and severe generalized chronic periodontitis
- Former diagnosis of hypertension
- >12 teeth
Who cannot join
- >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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Periodontitis, Hypertension
- Being tested
- echo Doppler lower limbs
- Medical subject headings
- Chronic Periodontitis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echo Doppler lower limbsOther
| Study group | Role | What they receive |
|---|---|---|
| blood and cardiological examination | Not described Receives: Other: echo Doppler lower limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the thickness of the intima-media
Measured: 15 days
Secondary outcomes (1)
Evaluation of anatomical changes that may occur at the arterial level
Measured: Within 15 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2024
- Study completionFeb 2024
Why it stopped: no patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier HUCK, MD, Principal investigator, CHRU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394860
- Sponsor's protocol ID
- 5883
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2014
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Periodontal Diseases on Hemodynamic and Molecular Vascular Parameters in Patients Suffering of Hypertension
- ClinicalTrials.gov ID
- NCT02394860
- Acronym / sponsor ID
- 5883
- Conditions
- Chronic Periodontitis, Hypertension
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: no patient
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Feb 2024 (actual)
- Study completion
- Feb 2024 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood and cardiological examination | – | Other: echo Doppler lower limbs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Will be included men with severe and moderate periodontitis
Key inclusion criteria (4 listed)
- -Men- >40 years
- moderate and severe generalized chronic periodontitis
- Former diagnosis of hypertension
- >12 teeth
Key exclusion criteria (6 listed)
- >70 years
- smokers (>10 cig/day)
- body mass index>30
- Need of antibioprophylaxis
- Medical treatment including anti-inflammatory drugs and/or antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echo Doppler lower limbs | Other | blood and cardiological examination |
Primary outcome
Measuring the thickness of the intima-media
Time frame: 15 days
1 secondary outcome
Evaluation of anatomical changes that may occur at the arterial level
Time frame: Within 15 days after inclusion
Results and safety
The study was stopped early (reason given: no patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier HUCK, MD principal investigator
CHRU Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Hypertension, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the thickness of the intima-media (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.