Status:
TERMINATED
Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Bruxism
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
Bruxism is defined as a parafunction that consists of a clenching of the jaw and/or grinding of the teeth. It can occur when an individual is sleeping or awake or it can be mixed. Most often, it is p...
Eligibility Criteria
Inclusion
- Patient who has given written consent.
- Patient between 18 and 64 years of age.
- Patient who has never received botulinum toxins
- Symptomatic patient in the context of bruxism in failure to the usual treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer)
- Woman of childbearing age using an effective method of contraception
- Symptomatic patients in the context of bruxism, without a maxillary disocclusion retainer.
Exclusion
- Protected Adult
- Patient not affiliated to the national health insurance system
- Pregnant or breastfeeding woman
- Refusal to take part in the study
- Neuromuscular diseases, including Myasthenia gravis, Myopathies, Amyotrophic Lateral Sclerosis. Lambert-Eaton Syndrome, patients with peripheral motor neuropathies, patients with underlying neurological disorders.
- Patients with a history of cardiovascular disease
- Patients with epilepsy or a previous seizure episode
- Neurogenic impairment of the face (including facial paralysis, polyradiculoneuritis)
- History of dysphagia or pulmonary aspiration
- Injection site infection (masseter and temporal)
- Hypersensitivity or allergy to botulinum toxin or any of its excipients.
- Treatment with aminoglycosides or anticholinesterase agents.
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04722809
Start Date
May 25 2022
End Date
August 31 2022
Last Update
August 26 2024
Active Locations (1)
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1
Chu Dijon Bourgogne
Dijon, France, 21000