Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology (Botox)
Primary Purpose
Bruxism
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Botulinum toxin injection
QOL-Brux
Muscular strength of the jaw
Intensity and frequency of episodes of nocturnal bruxism
visual analogue pain scale
Endobuccal and linea alba photographs
Sponsored by
About this trial
This is an interventional treatment trial for Bruxism
Eligibility Criteria
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.
Sites / Locations
- Chu Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Symptomatic patients in the context of bruxism
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04722809
First Posted
January 20, 2021
Last Updated
May 25, 2022
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT04722809
Brief Title
Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
Acronym
Botox
Official Title
Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Symptomatic patients in the context of bruxism
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin injection
Intervention Description
Injection in the temporal and masseter muscles: in 3 points in the masseter muscles and in 2 points in the temporal muscles.
Intervention Type
Other
Intervention Name(s)
QOL-Brux
Intervention Description
Questionnaire evaluating the symptoms of bruxism Inclusion and 3 months post-injection
Intervention Type
Other
Intervention Name(s)
Muscular strength of the jaw
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intensity and frequency of episodes of nocturnal bruxism
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
visual analogue pain scale
Intervention Description
Evaluation of jaw pain. At inclusion and 3 months post-injection
Intervention Type
Other
Intervention Name(s)
Endobuccal and linea alba photographs
Intervention Description
anonymous endobuccal and linea alba photographs (line on the inner face of the cheeks as the result of chronic friction).
At inclusion
Primary Outcome Measure Information:
Title
number of episodes of nocturnal bruxism
Description
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)
Time Frame
1 month after treatment by botulinum toxin injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Narcisse ZWETYENGA
Phone
03 80 29 37 57
Email
narcisse.zwetyenga@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Narcisse ZWETYENGA
Phone
03 80 29 37 57
Email
narcisse.zwetyenga@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
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