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

NCT ID: NCT04704128

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-05-12

Brief Summary

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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

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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.

Conditions

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Primary Burning Mouth Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group

women with primary stomatodynia

Salivic sample

Intervention Type OTHER

Collection of total saliva not stimulated

Control group

women without oral disease

Salivic sample

Intervention Type OTHER

Collection of total saliva not stimulated

Interventions

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Salivic sample

Collection of total saliva not stimulated

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahtab SAMIMI, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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Department of Dermatology, Hospital University of Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2020-A03435-34

Identifier Type: OTHER

Identifier Source: secondary_id

20.12.14.65838

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH3-RNI20-SESAME

Identifier Type: -

Identifier Source: org_study_id

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