Haemochromatosis and Periodontitis (HEMOPARO)

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 Overview

• Status: Completed
• Conditions: to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic
• Intervention / Treatment: Diagnostic test: dental probes

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: diagnostic test	Diagnostic test: dental probes; Measurement of the depth of the periodontal pockets and clinical loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2010
• Primary Completion (Actual): September 22, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Iron Metabolism Disorders; Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Iron Overload; Periodontitis; Periodontal Diseases; Hemochromatosis; Hemosiderosis
• Other Study ID Numbers: 2009-A00998-49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No