BruxismPhase 3BotoxNCT04722809
Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
A Phase 3 study testing Botulinum toxin injection, QOL-Brux and Muscular strength of the jaw in people with Bruxism, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Botulinum toxin injection, QOL-Brux and Muscular strength of the jaw
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2022to 31 Aug 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Botulinum toxin injection, QOL-Brux, Muscular strength of the jaw, Intensity and frequency of episodes of nocturnal bruxism, visual analogue pain scale
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injectionDrug
Injection in the temporal and masseter muscles: in 3 points in the masseter muscles and in 2 points in the temporal muscles.
QOL-BruxOther
Questionnaire evaluating the symptoms of bruxism Inclusion and 3 months post-injection
Muscular strength of the jawOther
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.
Intensity and frequency of episodes of nocturnal bruxismOther
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.
visual analogue pain scaleOther
Evaluation of jaw pain. At inclusion and 3 months post-injection
Endobuccal and linea alba photographsOther
anonymous endobuccal and linea alba photographs (line on the inner face of the cheeks as the result of chronic friction).
At inclusion
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic patients in the context of bruxism | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month after treatment by botulinum toxin injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start25 May 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Why it stopped: Difficulties in recruiting patients, compounded by problems extracting data from the device used in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722809
- Sponsor's protocol ID
- ZWETYENGA CRBFC 2020
- Acronym
- Botox
- Status last verified
- Aug 2024
- First submitted
- 20 Jan 2021
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
- ClinicalTrials.gov ID
- NCT04722809
- Acronym / sponsor ID
- Botox / ZWETYENGA CRBFC 2020
- Conditions
- Bruxism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting patients, compounded by problems extracting data from the device used in the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin injectionInjection in the temporal and masseter muscles: in 3 points in the masseter muscles and in 2 points in the temporal muscles. | Drug | Symptomatic patients in the context of bruxism |
| QOL-BruxQuestionnaire evaluating the symptoms of bruxism Inclusion and 3 months post-injection | Other | Symptomatic patients in the context of bruxism |
| Muscular strength of the jawMeasurement 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 | Symptomatic patients in the context of bruxism |
| Intensity and frequency of episodes of nocturnal bruxismMeasurements 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 | Symptomatic patients in the context of bruxism |
| visual analogue pain scaleEvaluation of jaw pain. At inclusion and 3 months post-injection | Other | Symptomatic patients in the context of bruxism |
| Endobuccal and linea alba photographsanonymous endobuccal and linea alba photographs (line on the inner face of the cheeks as the result of chronic friction). At inclusion | Other | Symptomatic patients in the context of bruxism |
Primary outcome
number of episodes of nocturnal bruxism
Time frame: 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)
Results and safety
The study was stopped early (reason given: Difficulties in recruiting patients, compounded by problems extracting data from the device used in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin injection, QOL-Brux and Muscular strength of the jaw in people with Bruxism, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting patients, compounded by problems extracting data from the device used in the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of episodes of nocturnal bruxism (time frame: 1 month after treatment by botulinum toxin injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.