An observational study in Primary Burning Mouth Syndrome, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by University Hospital, Tours · 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.
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.
44 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.
Browse Burning Mouth Syndrome studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Regarding the high predominance of this pathology among women and in order to optimize the study homogeneity, only women will be enrolled in this study.
In the control group, patients will be selected for having close characteristics with cases (pairing for age +/- 5 years and for sex).
Exclusion Criteria for both groups:
women with primary stomatodynia
Other: Salivic sample
women without oral disease
Other: Salivic sample
Collection of total saliva not stimulated
Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls
metabolites will be measured in saliva by chromatography-mass spectrometry
Time frame: at inclusion
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
Time frame: at inclusion
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
Time frame: at inclusion
Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls
quantitative assessment of levels of cytokines (IL-2, IL-6, IL-18, TNFα) will be assessed in saliva in cases and controls
Time frame: at inclusion
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)
Time frame: at inclusion
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Tours