Haemochromatosis and Periodontitis

NCT ID: NCT04006249

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-06
• Study Completion Date: 2011-12-01

Brief 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.

Conditions

to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

diagnostic test

Group Type: OTHER

dental probes

Intervention Type: DIAGNOSTIC_TEST

Measurement of the depth of the periodontal pockets and clinical loss

Interventions

dental probes

Measurement of the depth of the periodontal pockets and clinical loss

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2009-A00998-49

Identifier Type: -

Identifier Source: org_study_id