Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04006249
Other study ID # 2009-A00998-49
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2010
Est. completion date December 1, 2011

Study information

Verified date July 2019
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date December 1, 2011
Est. primary completion date September 22, 2011
Accepts healthy volunteers No
Gender All
Age group 35 Years to 64 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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).

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
dental probes
Measurement of the depth of the periodontal pockets and clinical loss

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 years