Clinical trial NCT04704128: Identification of Pathophysiological Pathways and Therapeutic Targets in Primary Stomatodynia by Salivary Metabolomics
Official title: Identification de Voies Physiopathologiques et Cibles thérapeutiques Dans la Stomatodynie Primaire (" Burning Mouth Syndrome ") Par la métabolomique Salivaire : étude Cas/témoins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Burning Mouth Syndrome
Keywords: Primary Burning Mouth Syndrome
Salivary metabolomic
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls
timeFrame: at inclusion
Secondary outcomes:
measure: Comparative analysis of salivary neuropeptides between cases (primary BMS) and controls
timeFrame: at inclusion
measure: Comparative analysis of salivary hormones between cases (primary BMS) and controls
timeFrame: at inclusion
measure: Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls
timeFrame: at inclusion
measure: Correlation between salivary biomarkers and pain characteristics
timeFrame: at inclusion
Other outcomes:
Locations:
city: Tours
country: France
facility: Department of Dermatology, Hospital University of Tours
Study officials:
affiliation: University Hospital, Tours
name: Mahtab SAMIMI, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: