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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Primary Burning Mouth Syndrome

Treatments: Other: Salivic sample

Study type: Observational

Funder types: Other

Identifiers

NCT04704128

RIPH3-RNI20-SESAME

2020-A03435-34 (Other Identifier)

20.12.14.65838 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

53 participants in 2 patient groups

Case group

Description:

women with primary stomatodynia

Treatment:

Other: Salivic sample

Control group

Description:

women without oral disease

Treatment:

Other: Salivic sample