- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686359
Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN) (OPIODYN)
Research of a Biological Marker for Chronic Orofacial Pain: Dosage of Opiorphin in Patients With Burning Mouth Syndrome
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Burning Mouth Syndrome Patients
saliva, blood and urinary samples
|
|
Active Comparator: controls
saliva, blood and urinary samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
opiorphin levels in saliva
Time Frame: Day 30
|
Day 30
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
opiorphin levels in blood
Time Frame: Day 30
|
Day 30
|
urinary levels in urine
Time Frame: Day 30
|
Day 30
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P081106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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