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

NCT02686359 | Completed

• 1 other identifier: P081106
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Burning Mouth Syndrome

Keywords

physiology; pain; analgesia; saliva; opiorphin

Outcome Measures

Primary Outcomes (1)

• opiorphin levels in saliva

  Day 30

Secondary Outcomes (2)

• opiorphin levels in blood

  Day 30

• urinary levels in urine

  Day 30

Study Arms (2)

Burning Mouth Syndrome Patients

EXPERIMENTAL

saliva, blood and urinary samples

Biological: sample

controls

ACTIVE COMPARATOR

saliva, blood and urinary samples

Biological: sample

Interventions

sample BIOLOGICAL

Burning Mouth Syndrome Patients; controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut Pasteur: collaborator

Related Publications (1)

• 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.

  PMID: 27834029 DERIVED

MeSH Terms

Conditions

Burning Mouth Syndrome; Pain; Agnosia

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 19, 2016
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 19, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share