Primary Burning Mouth SyndromeSESAMENCT04704128
Identification of Pathophysiological Pathways and Therapeutic Targets in Primary Stomatodynia by Salivary Metabolomics
An observational study of Primary Burning Mouth Syndrome, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Burning Mouth Syndrome
- What is being tested?
- Salivic sample
- Type of treatment
- Pill or oral medicine
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2021to 12 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older 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).
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Department of Dermatology, Hospital University of Tours
Tours, 37044
About this study
Official title: Identification de Voies Physiopathologiques et Cibles thérapeutiques Dans la Stomatodynie Primaire (" Burning Mouth Syndrome ") Par la métabolomique Salivaire : étude Cas/témoins
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.
Read the 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.
- Conditions
- Primary Burning Mouth Syndrome
- Being tested
- Salivic sample
- Keywords
- Primary Burning Mouth Syndrome, Salivary metabolomic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivic sampleOther
Collection of total saliva not stimulated
| Study group | Role | What they receive |
|---|---|---|
| Case group | women with primary stomatodynia Receives: Other: Salivic sample | |
| Control group | women without oral disease Receives: Other: Salivic sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls
metabolites will be measured in saliva by chromatography-mass spectrometry
Measured: at inclusion
Secondary outcomes (4)
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
Measured: at inclusion
Comparative analysis of salivary hormones between cases (primary BMS) and controls
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
Measured: at inclusion
Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls
quantitative assessment of levels of cytokines (IL-2, IL-6, IL-18, TNFα) will be assessed in saliva in cases and controls
Measured: at inclusion
Correlation between salivary biomarkers and pain characteristics
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)
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start10 Mar 2021
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Burning Mouth SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahtab SAMIMI, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704128
- Sponsor's protocol ID
- RIPH3-RNI20-SESAME
- Other IDs
- 2020-A03435-34, 20.12.14.65838
- Acronym
- SESAME
- Status last verified
- Jul 2021
- First submitted
- 7 Jan 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification de Voies Physiopathologiques et Cibles thérapeutiques Dans la Stomatodynie Primaire (" Burning Mouth Syndrome ") Par la métabolomique Salivaire : étude Cas/témoins
- ClinicalTrials.gov ID
- NCT04704128
- Acronym / sponsor ID
- SESAME / RIPH3-RNI20-SESAME
- Conditions
- Primary Burning Mouth Syndrome
- Keywords
- Primary Burning Mouth Syndrome, Salivary metabolomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Salivic samplewomen with primary stomatodynia |
| Control group | – | Other: Salivic samplewomen without oral disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivic sampleCollection of total saliva not stimulated | Other | Case group, Control group |
Primary outcome
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
4 secondary outcomes
Comparative analysis of salivary neuropeptides between cases (primary BMS) and controls
Time frame: at inclusion
Comparative analysis of salivary hormones between cases (primary BMS) and controls
Time frame: at inclusion
Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls
Time frame: at inclusion
Correlation between salivary biomarkers and pain characteristics
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahtab SAMIMI, MD-PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Burning Mouth Syndrome, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.