Primary Burning Mouth Syndrome Clinical Trial
— SESAMEOfficial title:
Identification de Voies Physiopathologiques et Cibles thérapeutiques Dans la Stomatodynie Primaire (" Burning Mouth Syndrome ") Par la métabolomique Salivaire : étude Cas/témoins
| Verified date | July 2021 |
| Source | University Hospital, Tours |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Burning mouth syndrome (BMS) is defined by a chronic oral pain affecting especially postmenopausal women. Its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. The recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. The aim of this study is to analyze the salivary metabolomic in BMS patients compared to healthy controls.
| Status | Completed |
| Enrollment | 53 |
| Est. completion date | May 12, 2021 |
| Est. primary completion date | May 12, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - For cases : primary Burning Mouth Syndrome, based on the IHS diagnosis criteria - For cases : being able to realise the salivary collection - For controls : no primary BMS - For controls : being able to realise the salivary collection Exclusion Criteria for both groups: - Treatment by antibiotics in the previous month - New treatment in the previous two weeks - Active smoking - Active infectious or inflammatory oral disease - Systemic disease that could have an impact on the salivary metabolome or on the neurological system - Being under legal guardianship - Opposition to the processing of personal data |
| Country | Name | City | State |
|---|---|---|---|
| France | Department of Dermatology, Hospital University of Tours | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Tours |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls | metabolites will be measured in saliva by chromatography-mass spectrometry | at inclusion | |
| Secondary | Comparative analysis of salivary neuropeptides between cases (primary BMS) and controls | quantitative assessment of levels of neuropeptides (NGF, histamine, tryptase, kallicrein) will be assessed in saliva in cases and controls | at inclusion | |
| Secondary | Comparative analysis of salivary hormones between cases (primary BMS) and controls | quantitative assessment of levels of steroid hormones (cortisol, 11-desoxycortisol, DHEA, SDHEA, progesterone, 17-hydroxyprogesterone, testosterone, androstenedione) will be assessed in saliva in cases and controls | at inclusion | |
| Secondary | Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls | quantitative assessment of levels of cytokines (IL-2, IL-6, IL-18, TNFa) will be assessed in saliva in cases and controls | at inclusion | |
| Secondary | Correlation between salivary biomarkers and pain characteristics | metabolites profile, salivary neuropeptides, hormones and cytokines will be compared according to the category of pain (type I-II-III, neuropathic pain score DN4>4) | at inclusion |