Hidradenitis Suppurativa and Periodontal Diseases (HSPDA)
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|ClinicalTrials.gov Identifier: NCT03553888|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : July 26, 2018
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|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
patients with HS
no HS patients
patients without HS
- Percentatge of peridontal disease in each groupe [ Time Frame: Day 0 ]Peridontal disease will be diagnosed based on clinical and radiographic examination
- 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.
- Salivary collection [ Time Frame: Day 0 ]During the periodontal consultation
- 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
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
|Contact: Sandrine LORIMIER||03 26 78 90 email@example.com|
|Contact: Stéphane DERRUAUfirstname.lastname@example.org|
|Contact: Sandrine LORIMIER (GRESPI, EA4694, Reims) 03 26 78 90 83 email@example.com|
|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)|