Haemochromatosis and Periodontitis

NCT04006249 | Completed

• 1 other identifier: 2009-A00998-49
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Hemochromatosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

diagnostic test

OTHER

Diagnostic Test: dental probes

Interventions

dental probes DIAGNOSTIC_TEST

Measurement of the depth of the periodontal pockets and clinical loss

diagnostic test

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, France

Location

MeSH Terms

Conditions

Hemochromatosis

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: June 6, 2010
• Primary Completion: September 22, 2011
• Study Completion: December 1, 2011
• Last Updated: June 12, 2026

Record last verified: 2019-07

Locations

FR (1)