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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Terminated

Phase 3

Conditions

Bruxism

Treatments

Other: Muscular strength of the jaw

Other: visual analogue pain scale

Other: Intensity and frequency of episodes of nocturnal bruxism

Other: QOL-Brux

Drug: Botulinum toxin injection

Other: Endobuccal and linea alba photographs

Study type

Interventional

Funder types

Other

Identifiers

NCT04722809

ZWETYENGA CRBFC 2020

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.