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Haemochromatosis and Periodontitis (HEMOPARO)

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

dental probes

About this trial

This is an interventional diagnostic trial for to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic

Eligibility Criteria

35 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

diagnostic test

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04006249

First Posted

July 1, 2019

Last Updated

July 1, 2019

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04006249

Brief Title

Haemochromatosis and Periodontitis

Acronym

HEMOPARO

Official Title

Haemochromatosis and Periodontitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

June 6, 2010 (Actual)

Primary Completion Date

September 22, 2011 (Actual)

Study Completion Date

December 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

diagnostic test

Arm Type

Other

Intervention Type

Diagnostic Test

Intervention Name(s)

dental probes

Intervention Description

Measurement of the depth of the periodontal pockets and clinical loss

Primary Outcome Measure Information:

Title

prevalence of periodontal diseases

Description

To evaluate the prevalence of periodontal diseases in patients with hemochromatosis at the time of diagnosis and / or their usual therapeutic

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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).

12. IPD Sharing Statement

Learn more about this trial

Haemochromatosis and Periodontitis

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