BruxismPhase 3NCT05980559
Evaluation of BTX Injections in Treatment of Bruxism
A Phase 3 study testing Xeomin in people with Bruxism, run by Alexandria University.
Trial summary
Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism. The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®)… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Xeomin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 15 Apr 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient between 20 and 60 years of age.
- Pain related to the masseter muscles and TMJ area due to bruxism.
- Patient who has never received botulinum toxins.
- Patient who did not respond to the conventional treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer).
Who cannot join
- Pregnant or breastfeeding women.
- Neuromuscular diseases, including neurogenic impairment of the face and patients with underlying neurological disorders.
- Patients with epilepsy or a previous seizure episode.
- Injection site infection (masseter or temporalis).
- Hypersensitivity or allergy to botulinum toxin or any of its excipients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Botulinum Toxin Injection in Treatment of Bruxism
Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism.
The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3 months after injection to determine the effect of treatment
Read the detailed description
Bruxism is a parafunctional activity of the masticatory muscles, characterized by jaw clenching and/or tooth grinding. It was suggested in international consensus conference that bruxism should have two distinct definitions. Sleep bruxism is a muscular action, either rhythmic or not, that takes place while sleeping, and an Awake bruxism which is a muscle disorder characterized by repeated or prolonged teeth contact with clenching of the jaw.
Bruxism is a highly prevalent condition. More than 85% of the general population admit to bruxism at some time during their life. According to reports, the prevalence of awake bruxism is about 24% in the adult population, while the prevalence of bruxism when sleeping is estimated to be around 16% of the same population.
The three muscles that responsible for the jaw closure and the majority of the biting force is the masseter, temporalis, and medial pterygoid muscles. About 43% of the intrinsic strength of jaw closure comes from the masseter, 36% from the temporalis, and 21% from the medial pterygoid.
The diagnosis of bruxism is made on the basis of self-reporting of clenching or grinding the teeth, as well as evaluating tooth mobility, tooth wear, bruxism-related sounds, or jaw muscle pain and other clinical findings of the temporo-mandibular joint (TMJ).
Bruxism has been noted in dentistry as a risk factor for tooth fracture and dental prosthesis damage, periodontal disease and possibly pain in the teeth, jaw, masticatory muscles, and temporo-mandibular joint. The etiology and pathophysiology of bruxism are still unknown, despite several potential causes have been suggested, including emotional stress, neurological diseases, specific medications, and occlusal interferences.
Physical therapy, occlusal splints, and pharmacological management have all been investigated as potential treatment modalities for bruxism, but they have not been proven to be completely effective because they mostly treat patients' symptoms and signs rather than treating the underlying cause of the condition. These treatment modalities helped only in limiting the damaging effects of bruxism on the anatomical structures.
Irreversible occlusal correction has been found ineffective and it is not supported by the available research. Occlusal splints have been applied to prevent overloading the temporomandibular joint elements and muscles of the jaw in addition to prevent tooth attrition. The efficacy of occlusal splints has given conflicting results.
Botulinum toxin (Botox) is currently known to be a useful treatment for a wide range of neurological conditions, and it is used for its therapeutic and cosmetic effect. It is formed by the anaerobic bacterium Clostridium botulinum and has paralytic properties as it can inhibit acetylcholine release, which can ultimately inhibit muscle contraction. Botulinum toxin comes in seven forms : A, B, C, D, E, F, and G. Type A, which cleaves the plasma protein SNAP-25, is the most commonly used commercially and clinically. It is injected intramuscularly, and its effect lasts between three and six months and this transient denervation depends on the dose and volume of toxin.
Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been experimented; initial results show that it is safe and effective. The injections generally take one week to start working and two weeks for a full effect, which lasts on average three to six months, and slowly wears off.
The purpose of this study is to evaluate the efficacy of injecting botulinum toxin A into the masseter muscle in participants with bruxism, using a pain scale, Electromyography and occlusense device.
The null hypothesis tested in this study is that there will be no significant difference in the pain level, muscles contractility and biting forces in patients injected with botulinum toxin
- Conditions
- Bruxism
- Being tested
- Xeomin
- Keywords
- Botulinum toxin, Electromyographic, occlusense
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XeominDrug
50 units of Incobotulinumtoxin A (BTX A) Xeomin® Injections into the masseter and temporalis muscles bilaterally (15 Units per muscle applied with 2 injections in each masseter muscle) (10 Units per muscle applied with 2 injections in each temporalis muscle)
| Study group | Role | What they receive |
|---|---|---|
| One Group | Experimental | Patients will be injected with 50 MU of botulinum toxin and Surface qualitative Electromyography, maximum bite force and visual pain scale will be taken before and after 1, 3 months Receives: Drug: Xeomin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in electromyographic activity of temporalis and masseter muscles bilaterally.
Analyze the electromyographic activity of temporalis and masseter muscles bilaterally. The acquisitions will be performed twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position for 5 seconds, and maximal teeth clenching with 10-mm thick cotton rolls between the posterior teeth for 5 seconds, bilaterally, and the median of values will be obtained. The unit of measurement used in the Electromyographic records will be microvolts (μV).
Measured: Assessment will be done before the injection versus 1 and 3 months after injection
Secondary outcomes (3)
Change in Pain Assessment
The pain will be measured using a visual analogue scale (VAS). The patient will be asked to mark on a line that measured 100 mm in length where she/he reflected her/his perceived pain. The scores of the scale will be determined by measuring the distance in mm from the beginning to the point indicated by the patient (point (0): no pain and point (100): the highest levels of pain).
Measured: Assessment will be done before the injection versus 1 and 3 months after injection
Change in maximum bite force
Computerized occlusal analysis will be conducted using the Occlusense device to record and analyze the biting force of each patient. The system use a 100-µm thick recording sensor. All scanning procedures will be carried out by the same clinician and at the same time of the day to avoid variability. The size of the sensor, large or small, will be chosen to suit the patient's dental arch. Prior to any occlusal acquisition sensitivity of the device will be adjusted. The patient will be asked to bite on the sensor, and a record for the maximum biting force on the first molar region (key of occlusion).
Measured: Assessment will be done before the injection versus 1 and 3 months after injection
Change in Bruxism symptom questionnaire
to evaluate the subjective bruxism symptoms consisted of three items: (1) How often do you think that you had bruxed at night during the past 1 month? (2) How often have you heard from your sleeping partner that you bruxed during the past 1 month? (3) How often during the past month have you felt jaw stiffness on waking? The responses to each item were based on a 0-5 scale where 0 = none, 1 = very seldom, 2 = seldom, 3 = often (half the mornings), 4 very often, 5 = every day. The rationale was that previous reports have used subjective measures, and we wished to compare our results with the previous data.
Measured: questionnaire will be done before the injection versus 1 and 3 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
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 Alexandria UniversityThe 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Ali Elwakil, Alexandria University
- Investigators
- Ragab S. Hassan, Professor, Study director, Alexandria UniversityGaafar N. Elhalawani, Lecturer, Study chair, Alexandria UniversityWalaa A. Elwakil, Lecturer, Study chair, University of AlexandriaMarwa M. Mancy, Bachelors, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980559
- Sponsor's protocol ID
- Botulinum toxin in bruxism
- Status last verified
- Jan 2024
- First submitted
- 22 Jun 2023
- Last updated
- 5 Jan 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Botulinum Toxin Injection in Treatment of Bruxism
- ClinicalTrials.gov ID
- NCT05980559
- Acronym / sponsor ID
- Botulinum toxin in bruxism
- Conditions
- Bruxism
- Keywords
- Botulinum toxin, Electromyographic, occlusense
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 8 Aug 2023 (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.
Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism.
The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3 months after injection to determine the effect of treatment
Detailed description
Bruxism is a parafunctional activity of the masticatory muscles, characterized by jaw clenching and/or tooth grinding. It was suggested in international consensus conference that bruxism should have two distinct definitions. Sleep bruxism is a muscular action, either rhythmic or not, that takes place while sleeping, and an Awake bruxism which is a muscle disorder characterized by repeated or prolonged teeth contact with clenching of the jaw.
Bruxism is a highly prevalent condition. More than 85% of the general population admit to bruxism at some time during their life. According to reports, the prevalence of awake bruxism is about 24% in the adult population, while the prevalence of bruxism when sleeping is estimated to be around 16% of the same population.
The three muscles that responsible for the jaw closure and the majority of the biting force is the masseter, temporalis, and medial pterygoid muscles. About 43% of the intrinsic strength of jaw closure comes from the masseter, 36% from the temporalis, and 21% from the medial pterygoid.
The diagnosis of bruxism is made on the basis of self-reporting of clenching or grinding the teeth, as well as evaluating tooth mobility, tooth wear, bruxism-related sounds, or jaw muscle pain and other clinical findings of the temporo-mandibular joint (TMJ).
Bruxism has been noted in dentistry as a risk factor for tooth fracture and dental prosthesis damage, periodontal disease and possibly pain in the teeth, jaw, masticatory muscles, and temporo-mandibular joint. The etiology and pathophysiology of bruxism are still unknown, despite several potential causes have been suggested, including emotional stress, neurological diseases, specific medications, and occlusal interferences.
Physical therapy, occlusal splints, and pharmacological management have all been investigated as potential treatment modalities for bruxism, but they have not been proven to be completely effective because they mostly treat patients' symptoms and signs rather than treating the underlying cause of the condition. These treatment modalities helped only in limiting the damaging effects of bruxism on the anatomical structures.
Irreversible occlusal correction has been found ineffective and it is not supported by the available research. Occlusal splints have been applied to prevent overloading the temporomandibular joint elements and muscles of the jaw in addition to prevent tooth attrition. The efficacy of occlusal splints has given conflicting results.
Botulinum toxin (Botox) is currently known to be a useful treatment for a wide range of neurological conditions, and it is used for its therapeutic and cosmetic effect. It is formed by the anaerobic bacterium Clostridium botulinum and has paralytic properties as it can inhibit acetylcholine release, which can ultimately inhibit muscle contraction. Botulinum toxin comes in seven forms : A, B, C, D, E, F, and G. Type A, which cleaves the plasma protein SNAP-25, is the most commonly used commercially and clinically. It is injected intramuscularly, and its effect lasts between three and six months and this transient denervation depends on the dose and volume of toxin.
Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been experimented; initial results show that it is safe and effective. The injections generally take one week to start working and two weeks for a full effect, which lasts on average three to six months, and slowly wears off.
The purpose of this study is to evaluate the efficacy of injecting botulinum toxin A into the masseter muscle in participants with bruxism, using a pain scale, Electromyography and occlusense device.
The null hypothesis tested in this study is that there will be no significant difference in the pain level, muscles contractility and biting forces in patients injected with botulinum toxin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Group | Experimental | Drug: XeominPatients will be injected with 50 MU of botulinum toxin and Surface qualitative Electromyography, maximum bite force and visual pain scale will be taken before and after 1, 3 months |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient between 20 and 60 years of age.
- Pain related to the masseter muscles and TMJ area due to bruxism.
- Patient who has never received botulinum toxins.
- Patient who did not respond to the conventional treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer).
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women.
- Neuromuscular diseases, including neurogenic impairment of the face and patients with underlying neurological disorders.
- Patients with epilepsy or a previous seizure episode.
- Injection site infection (masseter or temporalis).
- Hypersensitivity or allergy to botulinum toxin or any of its excipients.
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 |
|---|---|---|
| Xeomin50 units of Incobotulinumtoxin A (BTX A) Xeomin® Injections into the masseter and temporalis muscles bilaterally (15 Units per muscle applied with 2 injections in each masseter muscle) (10 Units per muscle applied with 2 injections in each temporalis muscle) | Drug | One Group |
Primary outcome
Change in electromyographic activity of temporalis and masseter muscles bilaterally.
Time frame: Assessment will be done before the injection versus 1 and 3 months after injection
Analyze the electromyographic activity of temporalis and masseter muscles bilaterally. The acquisitions will be performed twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position for 5 seconds, and maximal teeth clenching with 10-mm thick cotton rolls between the posterior teeth for 5 seconds, bilaterally, and the median of values will be obtained. The unit of measurement used in the Electromyographic records will be microvolts (μV).
3 secondary outcomes
Change in Pain Assessment
Time frame: Assessment will be done before the injection versus 1 and 3 months after injection
Change in maximum bite force
Time frame: Assessment will be done before the injection versus 1 and 3 months after injection
Change in Bruxism symptom questionnaire
Time frame: questionnaire will be done before the injection versus 1 and 3 months after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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.
Ragab S. Hassan, Professor study director
Alexandria University
Gaafar N. Elhalawani, Lecturer study chair
Alexandria University
Walaa A. Elwakil, Lecturer study chair
University of Alexandria
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xeomin in people with Bruxism, run by Alexandria University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa M. Mohmed, Bachelors (00201224979900, Marwa.mohamed.dent@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in electromyographic activity of temporalis and masseter muscles bilaterally. (time frame: Assessment will be done before the injection versus 1 and 3 months after 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 5 Jan 2024.