NCT04722809

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-25
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2021-01-25
• Last updated: 2024-08-26

Locations

1 site across 1 country: France