HemochromatosisHEMOPARONCT04006249
Haemochromatosis and Periodontitis
A study testing dental probes in people with Hemochromatosis, run by Rennes University Hospital at 1 site in France.
Trial summary
Periodontitis is a chronic inflammatory disease that affects tissues surrounding the teeth. It is strongly associated with the major pathogenic "red complex", including Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola1 and thus is considered an infection. Read more about this study
- Who is it for?
- Ages 35 to 64 years
- Conditions the study is for
- Hemochromatosis
- What is being tested?
- dental probes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2010to 1 Dec 2011
- Phase
- Interventional
- 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 35 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 35 to 64 years with homozygosity hemochromatosis C282Y
- Patients regularly enrolled in a health insurance plan
- Patients with at least 10 natural teeth
- Patients who have given informed written, dated and signed consent
Who cannot join
- Diabetic patients
- Simultaneous participation in another study
- Pregnant or lactating women
- The incapacitated persons and persons deprived of their liberty
- Patients who do not speak French, both written and spoken
- Patients previously included in this trial
Show all 11Show fewer
- Patients with heart valves or endovascular equipment (risk of infective endocarditis ...)
- Patients with a history of maxillofacial surgery
- Patients whose oral status is considered incompatible with entry into the study, at the discretion of the investigator
- Patients on drugs that can cause gingival hypertrophy, such as Hydantoins (phenytoin), Dihydropyridines, Diltiazem or Ciclosporin
- Patients on medication that can cause gingival bleeding (anticoagulants, antiplatelet agents and aspirin).
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis is a chronic inflammatory disease that affects tissues surrounding the teeth. It is strongly associated with the major pathogenic "red complex", including Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola1 and thus is considered an infection. Recent advances in the pathogenesis of periodontal disease have suggested that polymicrobial synergy and microbiota dysbiosis together with a dysregulated immune response can induce inflammation-mediated damage in periodontal tissues2-4. Interestingly, currently periodontitis is associated with a growing number of systemic diseases, including cardiovascular diseases, adverse pregnancy outcomes, diabetes5-7 and hereditary haemochromatosis8.
- Conditions
- Hemochromatosis
- Being tested
- dental probes
- Medical subject headings
- Hemochromatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental probesDiagnostic test
Measurement of the depth of the periodontal pockets and clinical loss
| Study group | Role | What they receive |
|---|---|---|
| diagnostic test | Other | Not described Receives: Diagnostic Test: dental probes |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of periodontal diseases
To evaluate the prevalence of periodontal diseases in patients with hemochromatosis at the time of diagnosis and / or their usual therapeutic
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Jun 2010
- Primary completion22 Sep 2011
- Study completion1 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemochromatosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006249
- Sponsor's protocol ID
- 2009-A00998-49
- Acronym
- HEMOPARO
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemochromatosis and Periodontitis
- ClinicalTrials.gov ID
- NCT04006249
- Acronym / sponsor ID
- HEMOPARO / 2009-A00998-49
- Conditions
- Hemochromatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 6 Jun 2010 (actual)
- Primary completion
- 22 Sep 2011 (actual)
- Study completion
- 1 Dec 2011 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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.
Periodontitis is a chronic inflammatory disease that affects tissues surrounding the teeth. It is strongly associated with the major pathogenic "red complex", including Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola1 and thus is considered an infection. Recent advances in the pathogenesis of periodontal disease have suggested that polymicrobial synergy and microbiota dysbiosis together with a dysregulated immune response can induce inflammation-mediated damage in periodontal tissues2-4. Interestingly, currently periodontitis is associated with a growing number of systemic diseases, including cardiovascular diseases, adverse pregnancy outcomes, diabetes5-7 and hereditary haemochromatosis8.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic test | Other | Diagnostic Test: dental probes |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 35 to 64 years with homozygosity hemochromatosis C282Y
- Patients regularly enrolled in a health insurance plan
- Patients with at least 10 natural teeth
- Patients who have given informed written, dated and signed consent
Key exclusion criteria (11 listed)
- Diabetic patients
- Simultaneous participation in another study
- Pregnant or lactating women
- The incapacitated persons and persons deprived of their liberty
- Patients who do not speak French, both written and spoken
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 |
|---|---|---|
| dental probesMeasurement of the depth of the periodontal pockets and clinical loss | Diagnostic test | diagnostic test |
Primary outcome
prevalence of periodontal diseases
Time frame: 2 years
To evaluate the prevalence of periodontal diseases in patients with hemochromatosis at the time of diagnosis and / or their usual therapeutic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental probes in people with Hemochromatosis, run by Rennes University Hospital 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 11 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: finished, as of the sponsor's last update on 12 Jun 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevalence of periodontal diseases (time frame: 2 years). 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 12 Jun 2026.