Identification of Pathophysiological Pathways and Therapeutic Targets in Primary Stomatodynia by Salivary Metabolomics

Completed

• Conditions: Primary Burning Mouth Syndrome
• Interventions: Other: Salivic sample

• Registration Number: NCT04704128
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Study Start: 2021-03-10
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Salivic sample	women without oral disease
Case group	Salivic sample	women with primary stomatodynia

Primary Outcome Measures

Name	Time	Method
Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls	at inclusion	metabolites will be measured in saliva by chromatography-mass spectrometry

Secondary Outcome Measures

Name	Time	Method
Comparative analysis of salivary neuropeptides between cases (primary BMS) and controls	at inclusion	quantitative assessment of levels of neuropeptides (NGF, histamine, tryptase, kallicrein) will be assessed in saliva in cases and controls
Comparative analysis of salivary hormones between cases (primary BMS) and controls	at inclusion	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
Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls	at inclusion	quantitative assessment of levels of cytokines (IL-2, IL-6, IL-18, TNFα) will be assessed in saliva in cases and controls
Correlation between salivary biomarkers and pain characteristics	at inclusion	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)

Trial Locations

Locations (1)

Department of Dermatology, Hospital University of Tours; 🇫🇷 Tours, France