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

NCT04722809 | Terminated Phase 3

• 1 other identifier: ZWETYENGA CRBFC 2020
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism

Outcome Measures

Primary Outcomes (1)

• number of episodes of nocturnal bruxism

  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)

  1 month after treatment by botulinum toxin injection

Study Arms (1)

Symptomatic patients in the context of bruxism

EXPERIMENTAL

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

Interventions

Botulinum toxin injection DRUG

Injection in the temporal and masseter muscles: in 3 points in the masseter muscles and in 2 points in the temporal muscles.

Symptomatic patients in the context of bruxism

QOL-Brux OTHER

Questionnaire evaluating the symptoms of bruxism Inclusion and 3 months post-injection

Symptomatic patients in the context of bruxism

Muscular strength of the jaw OTHER

Measurement in the jaw with a dynamometer connected to a sensor placed on the 1st molar on the right side. At inclusion and 1 month post-injection.

Symptomatic patients in the context of bruxism

Intensity and frequency of episodes of nocturnal bruxism OTHER

Measurements via a portable electromyography system, coupled with a heartbeat sensor (Bruxoff®). Measurements performed during normal sleeping conditions at home before injection and 1 month after.

Symptomatic patients in the context of bruxism

visual analogue pain scale OTHER

Evaluation of jaw pain. At inclusion and 3 months post-injection

Symptomatic patients in the context of bruxism

Endobuccal and linea alba photographs OTHER

anonymous endobuccal and linea alba photographs (line on the inner face of the cheeks as the result of chronic friction). At inclusion

Symptomatic patients in the context of bruxism

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Bruxism

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: May 25, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

FR (1)