Burning Mouth SyndromeOPIODYNNCT02686359
Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN)
A study testing sample in people with Burning Mouth Syndrome, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
If epidemiological studies indicate relatively low prevalence reported in the general population, idiopathic burning mouth syndrome (BMS) is a common condition among certain groups of the population: 30% of menopausal women experience oral burning to varying degrees . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2012
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Burning Mouth Syndrome
- Age between 18 and 80 years
- Sensation of pain in the oral mucosa, meeting the diagnostic criteria for BMS (Bergdahl and Anneroth, 1993, Scala 2003)
- Signature of informed consent
- Healthy volunteers
- Age between 18 and 80 years
- Patient age (+/- 5 years), sex and hormonal status (menopause or not for women) matched with a Burning Mouth Syndrome patient
- Signature of informed consent
Who cannot join
- Dental or periodontal pain during the month before the visit
- General pathology likely to cause mouth pain (diabetes, lupus, shingles, gastric reflux, allergies ...)
- Chronic Orofacial pain other than Burning Mouth Syndrome
- Treatment with a molecule able to induce oral burning sensations (anti-VEGF, neuroleptics, IEC angiotensin II ...)
- Participation concomitantly in biomedical research
- No affiliation to a social protection system
- Taste disorder other than a dysgeusia linked to Burning Mouth Syndrome
- Inability to understand the information note and sign the informed consent
About this study
Official title: Research of a Biological Marker for Chronic Orofacial Pain: Dosage of Opiorphin in Patients With Burning Mouth Syndrome
If epidemiological studies indicate relatively low prevalence reported in the general population, idiopathic burning mouth syndrome (BMS) is a common condition among certain groups of the population: 30% of menopausal women experience oral burning to varying degrees . Despite significant progress made in recent years, in understanding the physiopathogeny, treatment options remain limited and disappointing,resulting in an impairment of the quality of life. Given the chronic nature of idiopathic burning mouth syndrome, the need to identify the causes and effective treatment modalities for subjects suffering is essential.
Read the detailed description
Idiopathic burning mouth syndrome (BMS) is a chronic orofacial pain condition in which the pain is felt as intense, located on the tongue and the oral mucosa with no known cause. The pain may last for years and present treatments are of little effect. BMS is primarily a feminine disease, affecting women during or following menopause, suggesting an etiopathogenic role of the sexual hormones potentiating a local salivary factor. An anxiodepressive component is often associated with the disease. Recently, a molecule named opiorphin has been identified in human saliva. In animals, this molecule has shown potent analgesic properties comparable to those of morphine. The hypothesis of the investigators is that this molecule is in lower quantity in the saliva of persons suffering BMS and that this decrease causes oral burning sensations.
The main objective of the study is to test the hypothesis of a decrease of opiorphin levels in the saliva of patients suffering from primary BMS compared to a group of control subjects. The main judgment criteria is the level of salivary opiorphin in ng/mL.
The proposed study is a multicentric, simple blinded case controlled study. The investigators will collect the data from 21 primary BMS patients and 21 control subjects matched in sex, age, and hormonal status (menopause). The alpha risk is 0.5% and the power of the study is 90%.
Criteria for inclusion : BMS patients will be suffering for more than 4 months from burning pain in the tongue or oral mucosa with no organic trouble detectable by anamnesis, clinical evaluation and biological testing.
The design of the study includes three sessions for all subject of both groups; the maximum duration of participation for a subject is 8 weeks and the total duration of the study is 24 months There are two investigation centers.
- Conditions
- Burning Mouth Syndrome
- Being tested
- sample
- Keywords
- physiology, pain, analgesia, saliva, opiorphin
- Medical subject headings
- Burning Mouth Syndrome, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| Burning Mouth Syndrome Patients | Experimental | saliva, blood and urinary samples Receives: Biological: sample |
| controls | Active comparator | saliva, blood and urinary samples Receives: Biological: sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
opiorphin levels in saliva
Measured: Day 30
Secondary outcomes (2)
opiorphin levels in blood
Measured: Day 30
urinary levels in urine
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686359
- Sponsor's protocol ID
- P081106
- Acronym
- OPIODYN
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Boucher Y, Braud A, Dufour E, Agbo-Godeau S, Baaroun V, Descroix V, Guinnepain MT, Ungeheuer MN, Ottone C, Rougeot C. Opiorphin levels in fluids of burning mouth syndrome patients: a case-control study. Clin Oral Investig. 2017 Sep;21(7):2157-2164. doi: 10.1007/s00784-016-1991-0. Epub 2016 Nov 10.
PubMed 27834029
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of a Biological Marker for Chronic Orofacial Pain: Dosage of Opiorphin in Patients With Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT02686359
- Acronym / sponsor ID
- OPIODYN / P081106
- Conditions
- Burning Mouth Syndrome
- Keywords
- physiology, pain, analgesia, saliva, opiorphin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut Pasteur
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Feb 2016 (estimated)
- 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.
If epidemiological studies indicate relatively low prevalence reported in the general population, idiopathic burning mouth syndrome (BMS) is a common condition among certain groups of the population: 30% of menopausal women experience oral burning to varying degrees . Despite significant progress made in recent years, in understanding the physiopathogeny, treatment options remain limited and disappointing,resulting in an impairment of the quality of life. Given the chronic nature of idiopathic burning mouth syndrome, the need to identify the causes and effective treatment modalities for subjects suffering is essential.
Detailed description
Idiopathic burning mouth syndrome (BMS) is a chronic orofacial pain condition in which the pain is felt as intense, located on the tongue and the oral mucosa with no known cause. The pain may last for years and present treatments are of little effect. BMS is primarily a feminine disease, affecting women during or following menopause, suggesting an etiopathogenic role of the sexual hormones potentiating a local salivary factor. An anxiodepressive component is often associated with the disease. Recently, a molecule named opiorphin has been identified in human saliva. In animals, this molecule has shown potent analgesic properties comparable to those of morphine. The hypothesis of the investigators is that this molecule is in lower quantity in the saliva of persons suffering BMS and that this decrease causes oral burning sensations.
The main objective of the study is to test the hypothesis of a decrease of opiorphin levels in the saliva of patients suffering from primary BMS compared to a group of control subjects. The main judgment criteria is the level of salivary opiorphin in ng/mL.
The proposed study is a multicentric, simple blinded case controlled study. The investigators will collect the data from 21 primary BMS patients and 21 control subjects matched in sex, age, and hormonal status (menopause). The alpha risk is 0.5% and the power of the study is 90%.
Criteria for inclusion : BMS patients will be suffering for more than 4 months from burning pain in the tongue or oral mucosa with no organic trouble detectable by anamnesis, clinical evaluation and biological testing.
The design of the study includes three sessions for all subject of both groups; the maximum duration of participation for a subject is 8 weeks and the total duration of the study is 24 months There are two investigation centers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burning Mouth Syndrome Patients | Experimental | Biological: samplesaliva, blood and urinary samples |
| controls | Active comparator | Biological: samplesaliva, blood and urinary samples |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of Burning Mouth Syndrome
- Age between 18 and 80 years
- Sensation of pain in the oral mucosa, meeting the diagnostic criteria for BMS (Bergdahl and Anneroth, 1993, Scala 2003)
- Signature of informed consent
- Healthy volunteers
Key exclusion criteria (8 listed)
- Dental or periodontal pain during the month before the visit
- General pathology likely to cause mouth pain (diabetes, lupus, shingles, gastric reflux, allergies ...)
- Chronic Orofacial pain other than Burning Mouth Syndrome
- Treatment with a molecule able to induce oral burning sensations (anti-VEGF, neuroleptics, IEC angiotensin II ...)
- Participation concomitantly in biomedical research
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 |
|---|---|---|
| sample | Biological | Burning Mouth Syndrome Patients, controls |
Primary outcome
opiorphin levels in saliva
Time frame: Day 30
2 secondary outcomes
opiorphin levels in blood
Time frame: Day 30
urinary levels in urine
Time frame: Day 30
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 19 Feb 2016.
- Derived from this study: PubMed 27834029Boucher Y, Braud A, Dufour E, Agbo-Godeau S, Baaroun V, Descroix V, Guinnepain MT, Ungeheuer MN, Ottone C, Rougeot C. Opiorphin levels in fluids of burning mouth syndrome patients: a case-control study. Clin Oral Investig. 2017 Sep;21(7):2157-2164. doi: 10.1007/s00784-016-1991-0. Epub 2016 Nov 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sample in people with Burning Mouth Syndrome, run by Assistance Publique - Hôpitaux de Paris.
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 8 inclusion and 8 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
opiorphin levels in saliva (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02686359, which also lists 1 linked publication.
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 19 Feb 2016.