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

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.

Study Overview

• Status: Recruiting
• Conditions: Bruxism
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Narcisse ZWETYENGA; Phone Number: 03 80 29 37 57; Email: narcisse.zwetyenga@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Narcisse ZWETYENGA; Phone Number: 03 80 29 37 57; Email: narcisse.zwetyenga@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Symptomatic patients in the context of bruxism

Drug: Botulinum toxin injection; Injection in the temporal and masseter muscles: in 3 points in the masseter muscles and in 2 points in the temporal muscles.; Other: QOL-Brux; Questionnaire evaluating the symptoms of bruxism Inclusion and 3 months post-injection; Other: Muscular strength of the jaw; 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.; Other: Intensity and frequency of episodes of nocturnal bruxism; 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.; Other: visual analogue pain scale; Evaluation of jaw pain. At inclusion and 3 months post-injection; Other: Endobuccal and linea alba photographs; anonymous endobuccal and linea alba photographs (line on the inner face of the cheeks as the result of chronic friction). At inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Bruxism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: ZWETYENGA CRBFC 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No