Identification of Pathophysiological Pathways and Therape... | NCT04704128

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

NCT04704128

Sponsor

University Hospital, Tours

Status

Completed

Last Update Posted

Jul 7, 2021Actual

Enrollment

53Actual

Phase

Not provided

Conditions

Primary Burning Mouth Syndrome

Interventions

Salivic sample

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A03435-34	Other Identifier	IdRCB
20.12.14.65838	Other Identifier	SI CNRIPH

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2021Actual

Primary Completion Date

May 12, 2021Actual

Completion Date

May 12, 2021Actual

First Submitted Date

Jan 7, 2021

First Submission Date that Met QC Criteria

Jan 7, 2021

First Posted Date

Jan 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2021

Last Update Posted Date

Jul 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case group		women with primary stomatodynia	Other: Salivic sample
Control group		women without oral disease	Other: Salivic sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salivic sample	Other	Collection of total saliva not stimulated	Case group Control group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahtab SAMIMI, MD-PhD	University Hospital, Tours	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Hospital University of Tours		Tours		37044	France