Hidradenitis Suppurativa and Periodontal Diseases
מילות מפתח
תַקצִיר
תיאור
The principal hypothesis of this project is the existence of an association between Hidradenitis suppurativa (HS) and periodontal diseases (PD).
The primary objective is to evaluate this association using a multicenter cross-sectional clinical approach.
The secondary objectives are:
- To study the association between the severity of PD and the severity of HS.
- To search, using saliva collected from a population with clinical signs of HS and from no HS population, proteomic and metabolomic biosignatures by liquid chromatography tandem-mass spectrometry (LC-MS), by vibrational spectroscopies and by 1H-NMR spectroscopy.
- To compare vibrational biosignatures from saliva from patients with and without HS and / or MP to determine a unique salivary spectral profile of HS patients with and without PD.
- To compare the relevance of vibrational spectroscopy versus that of LC-MS and LC-MS / MS and 1H-NMR in the analysis of salivary markers identified from an overall non-targeted spectroscopy profile.
- To analyse and to compare proteomic and metabolomic biosignatures of unstimulated saliva samples depending on the severity of HS.
Will be included patients with HS (regardless of Hurley score) followed in the dermatology department of Reims University Hospital or the Institut Pasteur in Paris, and patients without HS from the service Odontology of the University Hospital of Reims or the Bretonneau Hospital (Paris) (whatever the reason for consultation), even also from the dermatology departments.
One hundred patients with HS will be included. At the same time, 100 patients without HS will be also included. Subjects without HS will be matched to subjects with HS on age (± 5 years). Given the percentage of non-HS patients for whom periodontal disease will be diagnosed (approximately 40%), this included number of patients will demonstrate an odds ratio of 2.6 (ie a percentage of patients with periodontal disease of 63% in the group with HS) with an α risk of 5% and a power of 90%.
The primary endpoint is the presence of periodontal disease in both patients with HS and without HS.
Diagnostic of periodontal disease will be posed in consultation by a periodontist and will be determined by clinical and radiographic assessments including in this research context:
i. Gingival bleeding (Bleeding on Probing, BOP) ii. Depth of periodontal pockets using a calibrated periodontal probe iii. Clinical attachment loss iiii. Interproximal bone loss. Bone loss will be taken in consideration when the distance between the alveolar ridge and the cement-enamel junction will be ≥ 2mm. A digital orthopantomogram will be performed with or without six retroalveolar X-rays of Ramfjord teeth.
Considering the bacterial etiology of periodontal diseases, it is important to note the amount of dental plaque directly in relation with the oral hygiene level performed with the dichotomous index "Plaque Control Record".
All these indexes will be assessed at six sites per tooth corresponding to a maximum of 168 values per patient. The third molar was excluded from analysis. The reliability of clinical measurements intra and inter- periodontists was verified. In retrospect, the causes of tooth loss will be sought.
The clinical diagnosis of HS will be based on the presence of recurrent abscesses in the folds, which can be multi-site, with residual scars according to the diagnosis criteria of European guidelines published in 2015.
Secondary endpoints
- The severity of HS will be based on the score of Hurley.
- The extent and severity of PD, their progression will be posed according to the "consensus" classification of periodontal diseases (Armitage et al., 1999). Periodontitis cases were defined according to CDC-AAP case definitions updated in 2012 (Eke et al., 2015).
- Semi-quantification and characterization of spectral biosignatures will be performed on saliva samples from patients with HS and non-HS patients.
Thus, at least 5mL of unstimulated saliva will be collected from HS or non-HS patients. The pH will be measured. They will be frozen at -80°C before analysis by liquid chromatography tandem-mass spectrometry and vibrational spectroscopies and, at -20°C by 1H-NMR spectroscopy.
תאריכים
אומת לאחרונה: | 03/31/2018 |
הוגש לראשונה: | 04/15/2018 |
ההרשמה המשוערת הוגשה: | 05/29/2018 |
פורסם לראשונה: | 06/11/2018 |
העדכון האחרון הוגש: | 07/23/2018 |
עדכון אחרון פורסם: | 07/25/2018 |
תאריך תחילת לימוד בפועל: | 05/06/2018 |
תאריך סיום משוער משוער: | 11/06/2019 |
תאריך סיום משוער ללימודים: | 05/06/2020 |
מצב או מחלה
שלב
קבוצות זרועות
זְרוֹעַ | התערבות / טיפול |
---|---|
HS patient patients with HS | |
no HS patients patients without HS |
קריטריונים לזכאות
גילאים הזכאים ללימודים | 18 Years ל 18 Years |
מינים הזכאים ללימודים | All |
שיטת דגימה | Non-Probability Sample |
מקבל מתנדבים בריאים | כן |
קריטריונים | 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. |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Percentatge of peridontal disease in each groupe [Day 0]
2. Questionnaire [Day 0]
אמצעי תוצאה משניים
1. Salivary collection [Day 0]
2. Salivary proteomic and metabolomic biosignatures in each group [Month 6]