Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04704128
Acronym
SESAME
Enrollment
53
Registered
2021-01-11
Start date
2021-03-10
Completion date
2021-05-12
Last updated
2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Burning Mouth Syndrome

Keywords

Primary Burning Mouth Syndrome, Salivary metabolomic

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.

Interventions

OTHERSalivic sample

Collection of total saliva not stimulated

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controlsat inclusionmetabolites will be measured in saliva by chromatography-mass spectrometry

Secondary

MeasureTime frameDescription
Comparative analysis of salivary neuropeptides between cases (primary BMS) and controlsat inclusionquantitative 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 controlsat inclusionquantitative 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 controlsat inclusionquantitative 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 characteristicsat inclusionmetabolites profile, salivary neuropeptides, hormones and cytokines will be compared according to the category of pain (type I-II-III, neuropathic pain score DN4\>4)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026