Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
- Conditions
- Bruxism
- Registration Number
- NCT04722809
- Lead Sponsor
- Centre Hospitalier Universitaire Dijon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria:<br><br> - Patient who has given written consent.<br><br> - Patient between 18 and 64 years of age.<br><br> - Patient who has never received botulinum toxins<br><br> - Symptomatic patient in the context of bruxism in failure to the usual treatments<br> (analgesic, physiotherapy, relaxation technique and maxillary retainer)<br><br> - Woman of childbearing age using an effective method of contraception<br><br> - Symptomatic patients in the context of bruxism, without a maxillary disocclusion<br> retainer.<br><br>Exclusion Criteria:<br><br> - Protected Adult<br><br> - Patient not affiliated to the national health insurance system<br><br> - Pregnant or breastfeeding woman<br><br> - Refusal to take part in the study<br><br> - Neuromuscular diseases, including Myasthenia gravis, Myopathies, Amyotrophic Lateral<br> Sclerosis. Lambert-Eaton Syndrome, patients with peripheral motor neuropathies,<br> patients with underlying neurological disorders.<br><br> - Patients with a history of cardiovascular disease<br><br> - Patients with epilepsy or a previous seizure episode<br><br> - Neurogenic impairment of the face (including facial paralysis, polyradiculoneuritis)<br><br> - History of dysphagia or pulmonary aspiration<br><br> - Injection site infection (masseter and temporal)<br><br> - Hypersensitivity or allergy to botulinum toxin or any of its excipients.<br><br> - Treatment with aminoglycosides or anticholinesterase agents.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method number of episodes of nocturnal bruxism
- Secondary Outcome Measures
Name Time Method