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

Phase 3

Terminated

• Conditions: Bruxism
• Interventions: Drug: Botulinum toxin injection; Other: QOL-Brux; Other: Muscular strength of the jaw; Other: Intensity and frequency of episodes of nocturnal bruxism; Other: visual analogue pain scale; Other: Endobuccal and linea alba photographs

• Registration Number: NCT04722809
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-25
• Study Start: 2022-05-25
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Symptomatic patients in the context of bruxism	Botulinum toxin injection	-
Symptomatic patients in the context of bruxism	visual analogue pain scale	-
Symptomatic patients in the context of bruxism	Muscular strength of the jaw	-
Symptomatic patients in the context of bruxism	Intensity and frequency of episodes of nocturnal bruxism	-
Symptomatic patients in the context of bruxism	QOL-Brux	-
Symptomatic patients in the context of bruxism	Endobuccal and linea alba photographs	-

Primary Outcome Measures

Name	Time	Method
number of episodes of nocturnal bruxism	1 month after treatment by botulinum toxin injection	measurement of the number of bruxism episodes via a portable electromyogram we expect a significant improvement in the number of nocturnal bruxism episodes (decrease in relation to time 0)

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France