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

Identification de Voies Physiopathologiques et Cibles thérapeutiques Dans la Stomatodynie Primaire (" Burning Mouth Syndrome ") Par la métabolomique Salivaire : étude Cas/témoins

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 Overview

• Status: Completed
• Conditions: Primary Burning Mouth Syndrome
• Intervention / Treatment: Other: Salivic sample

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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Department of Dermatology, Hospital University of Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; women with primary stomatodynia	Other: Salivic sample; Collection of total saliva not stimulated
Control group; women without oral disease	Other: Salivic sample; Collection of total saliva not stimulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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	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)	at inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Mahtab SAMIMI, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2021
• Primary Completion (ACTUAL): May 12, 2021
• Study Completion (ACTUAL): May 12, 2021

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (ACTUAL): January 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Primary Burning Mouth Syndrome; Salivary metabolomic
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome
• Other Study ID Numbers: RIPH3-RNI20-SESAME; 2020-A03435-34 (OTHER: IdRCB); 20.12.14.65838 (OTHER: SI CNRIPH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No