Botulinum Toxin Injections for Oral Neuropathic Pain

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 1, 2018

Keywords

ClinConnect Summary

Traumas of either physical (shocks, ballistic impacts etc.) or surgical origin are accompanied by acute pain which disappears in most cases with tissue healing. However, in some instances pain may persist in spite of an apparently normal tissue repair. Many reports have pointed to the societal impact of these neuropathic pains which is a major public health problem in Europe and in the world. In addition to the degradation of the quality of individual life that affects hedonistic, emotional, social, professional etc. dimensions of life, the economic cost to society is considerable (treatmen...

Gender

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Eligibility criteria

• • Inclusion criteria
• • 1. Informed consent form signed
• • 2. Adult patients, age 18 -75 y.o.
• • 3. Medical coverage (excepted AME)
• • 4. Understanding of all medical information
• • 5. Subjects fulfilling diagnostic criteria for Peripheral painful traumatic trigeminal neuropathy (PPTTN)
• • 6. Pain in one or several branches of the trigeminal nerve
• • 7. History of surgical treatment (including endodontic treatments) in the painful area
• • 8. Pain in the area experienced in the 3 months following the treatment
• • 9. pain almost every day for at least 6 months
• • 10. VAS ≥ 30 /100 mm
• • 11. Primary painful area limited to one dental quadrant
• • 12. Presence of at least one positive (hyperalgesia, allodynia, numbness or swelling) and/or negative (anesthesia or hypoesthesia) sign of neurological dysfunction
• • 13. Pain cannot be attributed to another cause
• • Exclusion criteria
• • 1. Patients with impaired communication
• • 2. Pregnancy, breastfeeding or planning pregnancy within the period of the study
• • 3. Women of childbearing potential (WOCBP), adequate method of contraception within the period of the study
• • 4. Orofacial pain other than PPTTN unless clearly identifiable TMD (arthralgia, muscle pain or disc displacement)
• • 5. Contra-indications for BTX-A (for example diseases of the neuromuscular junction, known hypersensitivity to BTX-A etc.)
• • 6. Known coagulation disorders
• • 7. Major depression (score \> XX HADS scale)
• • 8. Background of drug consumption or excessive alcohol consumption (3 units of alcohol a day)
• • 9. current legal dispute with a dental practitioner
• • 10. Former use of BTX for esthetic purpose
• • 11. Dysphagia
• • 12. Aspiration pneumonitis
• • 13. Troubles with bladder control
• • 14. Concomitant use of analgesics with dosage modification since less one month before inclusion in the study
• • 15. Topical applications of drugs and anesthetics which cannot be interrupted one week before visit sessions
• • 16. Treatment with aminoglycosides in the three months preceding the selection
• • 17. Participation to another interventional clinical study