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Completed

NCT Number: NCT04704128

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Dermatology, Hospital University of Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salivic sample

Other

Collection of total saliva not stimulated

Primary outcomes

  1. Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls

    Time frame: at inclusion

    metabolites will be measured in saliva by chromatography-mass spectrometry

Secondary outcomes

  1. Comparative analysis of salivary neuropeptides between cases (primary BMS) and controls

    Time frame: at inclusion

    quantitative assessment of levels of neuropeptides (NGF, histamine, tryptase, kallicrein) will be assessed in saliva in cases and controls

  2. Comparative analysis of salivary hormones between cases (primary BMS) and controls

    Time frame: 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

  3. Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls

    Time frame: at inclusion

    quantitative assessment of levels of cytokines (IL-2, IL-6, IL-18, TNFα) will be assessed in saliva in cases and controls

  4. Correlation between salivary biomarkers and pain characteristics

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: SESAME

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.