CompletedNot Applicable

Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN)

42 participantsStarted 2011-07

Plain-language 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 . 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

opiorphin levels in saliva

Timeframe: Day 30

Trial details

NCT IDNCT02686359

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Burning Mouth Syndrome trials