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出境医 / 临床实验 / Haemochromatosis and Periodontitis (HEMOPARO)

Haemochromatosis and Periodontitis (HEMOPARO)

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.

Condition or disease Intervention/treatment Phase
to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic Diagnostic Test: dental probes Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Haemochromatosis and Periodontitis
Actual Study Start Date : June 6, 2010
Actual Primary Completion Date : September 22, 2011
Actual Study Completion Date : December 1, 2011
Arms and Interventions
Arm Intervention/treatment
diagnostic test Diagnostic Test: dental probes
Measurement of the depth of the periodontal pockets and clinical loss
Outcome Measures
Primary Outcome Measures :
  1. prevalence of periodontal diseases [ Time Frame: 2 years ]
    To evaluate the prevalence of periodontal diseases in patients with hemochromatosis at the time of diagnosis and / or their usual therapeutic


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE June 6, 2010
Actual Primary Completion Date September 22, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		prevalence of periodontal diseases [ Time Frame: 2 years ]
To evaluate the prevalence of periodontal diseases in patients with hemochromatosis at the time of diagnosis and / or their usual therapeutic
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Haemochromatosis and Periodontitis
Official Title  ICMJE Haemochromatosis and Periodontitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic
Intervention  ICMJE Diagnostic Test: dental probes
Measurement of the depth of the periodontal pockets and clinical loss
Study Arms  ICMJE diagnostic test
Intervention: Diagnostic Test: dental probes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2019) 		87
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2011
Actual Primary Completion Date September 22, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04006249
Other Study ID Numbers  ICMJE 2009-A00998-49
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rennes University Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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