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Hidradenitis Suppurativa and Periodontal Diseases (HSPDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553888
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborators:
Association Française pour la Recherche sur l'Hidrosadénite (Financial sponsor)
Association Française d'épargne et de retraite (Financial sponsor)
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

Hidradenitis suppurativa or Verneuil's disease (HS) is a neglected and often overlooked chronic inflammatory skin disease. Nevertheless, it is frequent (1% of the general population) and deeply affects quality of life in patients with moderate and severe forms of HS. This disease is characterized by the occurrence of deep, recurrent and painful nodules, progressing to abscess formation and suppuration. It is usually localized in the axillary, inguinal and anogenital areas. The pathogenesis of HS remains partly unknown but is probably multifactorial (inflammatory, genetic, infectious, etc.) and related to many risk factors (mostly smoking and obesity). An association can be found with other inflammatory diseases such as gastrointestinal and rheumatic diseases like Crohn's disease and spondylo-arthritis respectively.

Periodontal diseases are a heterogeneous group of infectious diseases with an inflammatory component. Their clinical expression results in more or less rapid destruction of tooth supporting tissues. Without treatment, these lesions may progress ultimately to tooth exfoliation, the rate of disease progression being unevenly distributed in the population. Various epidemiological studies in France indicate that 12 to 13% of middle-aged adults have severe periodontal damage. In addition, a recent study shows that while 50% of adults in France are suffering from severe attachment loss, generalized forms are rare and about 10% of individuals seem to require special care. The bacterial factor is the main etiological factor of these diseases but their progression depends primarily on the host immune response and on modifying factors (genetic, systemic, environmental and behavioural). Some of these factors are identified such as uncontrolled diabetes, smoking, stress, etc.. Finally, it is well established that periodontal disease may also trigger the development of some systemic diseases such as diabetes.

Thus, many common etiopathogenic factors between HS and periodontal diseases such as inflammatory components and tobacco are found. This is corroborated by observations collected from some patients with HS complaining of oral pain exacerbated during acute flares of HS. Hence the aim of this project is to clarify existing potential association between Hidradenitis suppurativa and periodontal diseases using a multicenter cross-sectional descriptive clinical approach.

One hundred patients with HS will be included in the departments of dermatology at the University Hospital in Reims and at the Pasteur Institute in Paris. They will be compared with one hundred patients without HS recruited from "general practice" consultations in the departments of Odontology at the University Hospital in Reims and at Bretonneau Hospital in Paris.

The severity of HS will be assessed with Hurley's score by the dermatologist. The periodontal status will be evaluated with clinical indices and radiographical parameters by a periodontist according to the "Armitage" classification of periodontal disease and to CDC-AA case definitions updated in 2012. Meanwhile, human saliva is a biological fluid taken to reflect the health status of an individual and is or may be used for diagnosis and prognosis of some oral cancers, some systemic diseases (type 2 diabetes, sarcoidosis, etc.) or periodontal diseases. The saliva will be collected and analysed by proteomics and metabolomics techniques in order to identify biomarkers for diagnosis and prognostic of HS associated or not to periodontal diseases.

These unpublished works could demonstrate a predisposition to develop periodontal disease in a subgroup of HS patients and help to unravel new etiopathogenic mechanisms common to both diseases as well as ultimately lead to early periodontal management in order to avoid disease progression and tooth losses.


Condition or disease
Hidradenitis Suppurativa Periodontal Diseases

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Relationship Between Hidradenitis Suppurativa and Periodontal Diseases
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : November 7, 2019
Estimated Study Completion Date : May 7, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
HS patient
patients with HS
no HS patients
patients without HS



Primary Outcome Measures :
  1. Percentatge of peridontal disease in each groupe [ Time Frame: Day 0 ]
    Peridontal disease will be diagnosed based on clinical and radiographic examination

  2. Questionnaire [ Time Frame: Day 0 ]
    Socio-demographic data (age, sex, etc.) and clinical data (medical history, skin symptoms, etc.) will be collected for all patients included in the study.


Secondary Outcome Measures :
  1. Salivary collection [ Time Frame: Day 0 ]
    During the periodontal consultation

  2. Salivary proteomic and metabolomic biosignatures in each group [ Time Frame: Month 6 ]
    These will be investigated using spectroscopy and liquid chromatography coupled with tandem mass spectrometry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Will be included in the study as HS-patients who:

  • Have a HS (regardless of the Hurley score) according to the criteria of EU Guidelines on the HS.
  • Are followed-up in departments of dermatology in Reims University Hospital or at Pasteur Institute in Paris.
  • Are older than 18 years.
  • Signed the informed consent form to take part in the study.
  • Are affiliated to a social insurance.

Will be included in the study as no-HS patients who:

  • Are not suffering from HS. Are followed-up in departments of odontology in Reims or at Bretonneau hospital in Paris (regardless of the reason for consultation), even also from the dermatology departments.
  • Are older than 18 years.
  • Signed the informed consent form to take part in the study.
  • Are affiliated to a social insurance.
Criteria

Inclusion Criteria:

Will be included in the study as HS-patients who:

  • Have a HS (regardless of the Hurley score) according to the criteria of EU Guidelines on the HS.
  • Are followed-up in departments of dermatology in Reims University Hospital or at Pasteur Institute in Paris.
  • Are older than 18 years.
  • Signed the informed consent form to take part in the study.
  • Are affiliated to a social insurance.

Will be included in the study as no-HS patients who:

  • Are not suffering from HS. Are followed-up in departments of odontology in Reims or at Bretonneau hospital in Paris (regardless of the reason for consultation), even also from the dermatology departments.
  • Are older than 18 years.
  • Signed the informed consent form to take part in the study.
  • Are affiliated to a social insurance.

Exclusion Criteria:

  • Are suffering from a systemic disease or condition known to have an impact on periodontal level (leukemia, Down syndrome, uncontrolled diabetes, etc.).
  • Are pregnant or lactating: these will be excluded because of the changes of periodontal status associated with pregnancy.
  • Have a history of periodontal treatment of less than 3 months.
  • Show an infectious risk contraindicating periodontal probing (considered as an invasive act because of the induced bacteremia). ANDEM and the Consensus Conference of 2011 identified these patients.
  • Are under medication known to cause changes in the gingival level as drug gingival hypertrophy including sodium diphenylhydantoïne, nifedipine, ciclosporin A.
  • Are protected by law.

Exposed and unexposed patients having periodontal disease known before inclusion can take part in this research protocol.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553888


Contacts
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Contact: Sandrine LORIMIER 03 26 78 90 83 sandrine.lorimier@univ-reims.fr
Contact: Stéphane DERRUAU sderruau@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Sandrine LORIMIER (GRESPI, EA4694, Reims)    03 26 78 90 83    sandrine.lorimier@univ-reims.fr   
Sub-Investigator: Stéphane DERRUAU (Biospect, EA7506; Oral Medicine Department,Reims)         
Sub-Investigator: Manuelle VIGUIER (Department of Dermatology, Reims)         
Sub-Investigator: Yohann RENARD (Department of surgery, Reims)         
Sub-Investigator: Aude NASSIF (Institut Pasteur, Paris)         
Sub-Investigator: Dominique GUEZ (Department of Odontology, Hôpital Bretonneau; Paris)         
Sub-Investigator: Maia DELAGE-TORIEL (Institut Pasteur, Paris)         
Sponsors and Collaborators
CHU de Reims
Association Française pour la Recherche sur l'Hidrosadénite (Financial sponsor)
Association Française d'épargne et de retraite (Financial sponsor)

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03553888    
Other Study ID Numbers: PO18056
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Hidradenitis Suppurativa
Periodontal diseases
Multicenter cross-sectional study
Vibrational spectroscopies
Salivary biomarkers
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration