Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology (Botox)

  • End date
    Feb 6, 2024
  • participants needed
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 6 June 2022


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 primary or idiopathic bruxism, however when it is related to a cause it is qualified as secondary.

Primary bruxism is a condition that is not well known to the general public, but I is very widespread (12% of the adult population). In addition, it can alter quality of life, as a result of associated sleep disorders, concentration disorders, daytime fatigue, chronic pain, etc.

The current treatment for this condition is only symptomatic. Currently, one of the most effective treatments is the intramuscular injection of botulinum toxin A in the muscles of mastication. The progressive anticholinergic action results in a reduction of functional signs (dental pain, periodontal pain, temporomandibular joint pain, tension headaches, neck pain) and physical signs (reduction of the mass of the injected muscles, alba linea, tongue scalloping, limitation or stability of dental damage).

However, these clinical data are practically not objectified in daily practice. Objective criteria would make it possible to measure the effectiveness of the treatment, to follow the patient, and to identify the early symptoms in order to prevent a recurrence.

The aim of the prospective study is to concretely measure the strength and electromyographic activity of the muscles of mastication before and after botulinum toxin injection.

Condition Bruxism
Treatment botulinum toxin injection, QOL-Brux, Muscular strength of the jaw, Intensity and frequency of episodes of nocturnal bruxism, visual analogue pain scale, Endobuccal and linea alba photographs
Clinical Study IdentifierNCT04722809
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on6 June 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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