BruxismPhase 4NCT00908050
Study of the Safety and Efficacy of Botox in Bruxism
A Phase 4 study testing Botulinum toxin type A in people with Bruxism, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether botulinum toxin helps patients with bruxism. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients between the ages of 18 and 80 years old with a diagnosis of bruxism, based on the standard criteria.
- 2. If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, or otherwise be incapable of pregnancy, or have practiced a method of contraception (hormonal contraceptives, spermicidal barrier, intrauterine device, partner sterility) at least one month prior to study entry. Any female of childbearing age will have a urine pregnancy test one week prior to the treatment (visit 2).
- 3. Ability of the patient or guardian to sign and understand informed consent.
- 4. Ability to follow and comply with study directions.
Who cannot join
- 1. Coexistence of active psychosis, other active psychiatric disease or cognitive impairment.
- 2. Coexistence of serious co-morbid conditions.
- 3. Exposure to any botulinum toxin preparation within the past 6 months.
- 4. Participation in another experimental therapeutic protocol within 30 days.
- 5. Any medical condition in which the administration of botulinum toxin is contraindicated, including myasthenia gravis, amyotrophic lateral sclerosis or other neuromuscular diseases.
- 6. History of dysphagia.
Show all 12Show fewer
- 7. History of botulism.
- 8. A condition or situation in which the investigators view will confound the ability of the subject to participate in the study.
- 9. Patients or guardian who are unable to understand and sign informed consent.
- 10. Pregnancy
- 11. Patients who do not meet inclusion criteria.
- 12. Patients in whom it is felt that a major portion of overall sleep morbidity is not related to bruxism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placeboa-controlled, Randomized Clinical Trial of the Safety and Efficacy of Botulinum Toxin (BOTOX) in Bruxism.
The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.
Read the detailed description
Bruxism represents involuntary movements of the jaw muscles, resulting in tooth grinding and clenching. Generally it occurs during sleep, but occasionally can be present during the day, so called awake bruxism. Bruxism is a common condition, affecting approximately 8% of all people. It is not known what causes bruxism but it may result in tooth damage, jaw pain, headaches, poor quality sleep and may bother your partner's sleep at night due to the tooth grinding noise. There is no generally accepted treatment for bruxism. Mouth guards and several medications have been tried, but they generally did not work or caused side effects.
Botulinum toxin "Botox" is a natural toxin, which weakens the muscles when injected in very small amounts. It is currently approved and used for the treatment of various conditions involving abnormal muscle spasms, such as neck twisting (torticollis), twitching of the face (hemifacial spasm) or eyes (blepharospasm), headaches, muscles stiffness following strokes, and it has also been used cosmetically for wrinkle removal.
Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been tried, initial results showing that it is safe and effective. The injections generally take one week to start working and 2 weeks for a full effect, which lasts on average 12-16 weeks, and slowly wear off. The injections are generally repeated every 3-4 months.
- Conditions
- Bruxism
- Being tested
- Botulinum toxin type A, Placebo arm
- Keywords
- bruxism, botulinum toxin, sleep study
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botulinum toxin type A (Botox)
Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.
Placebo armDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo arm Receives: Drug: Placebo arm |
| botulinum toxin type A | Active comparator | Active arm Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruxism Questionnaire Baseline and at Week 4
Baseline assessments included a bruxism questionnaire with a modified quantifiable portion [Lavigne G. with permission]. This is compared to week 4 assessments. The bruxism questionnaire consists of 8 questions. Each question can be scored between 0-3 points for a total possible scoring of 24 points. The minimum score is 0. The maximum score if 24. A score of 3 or less means non-temporomandibular disorder. A score of 4 or more means temporomandibular disorder.
Measured: baseline versus week 4
Secondary outcomes (4)
Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4
Baseline assessments included HIT-6 questionnaire. This is compared to week 4 assessments. The Headache Impact Test consists of 6 questions. Each question can be scored between 6 to 13 points for a possible total of 78 points. A total score of 50 or more means the patient has migraines. A score of 49 or less means the patient has headaches, not migraines. The minimum score if 36. The maximum score is 78 points.
Measured: Baseline to week 4
Clinical Global Impression (CGI)
With this scale the clinical evaluates the patient and gives the patient a single score based off of the evaluation. The score given can be between 1 and 7 where 1 means the patient is normal and 7 means the patient is amongst the most severely ill. The minimum score if 1. The maximum score is 7.
Measured: baseline versus week 4
Visual Analog Scale of Change (VAS)-Pain Scale
Visual Analog scale of change (VAS) (0-100) comparing delta of pre-versus post-injection.The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum score if 100.
Measured: baseline versus week 4
Visual Analog Scale of Change (VAS)-Pain
The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum sore if 100.
Measured: Baseline versus week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Joseph Jankovic, Baylor College of Medicine
- Investigators
- William G Ondo, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908050
- Sponsor's protocol ID
- H-22737
- Status last verified
- Jun 2023
- First submitted
- 21 May 2009
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placeboa-controlled, Randomized Clinical Trial of the Safety and Efficacy of Botulinum Toxin (BOTOX) in Bruxism.
- ClinicalTrials.gov ID
- NCT00908050
- Acronym / sponsor ID
- H-22737
- Conditions
- Bruxism
- Keywords
- bruxism, botulinum toxin, sleep study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Apr 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 May 2009 (estimated)
- Results
- Posted 8 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.
Detailed description
Bruxism represents involuntary movements of the jaw muscles, resulting in tooth grinding and clenching. Generally it occurs during sleep, but occasionally can be present during the day, so called awake bruxism. Bruxism is a common condition, affecting approximately 8% of all people. It is not known what causes bruxism but it may result in tooth damage, jaw pain, headaches, poor quality sleep and may bother your partner's sleep at night due to the tooth grinding noise. There is no generally accepted treatment for bruxism. Mouth guards and several medications have been tried, but they generally did not work or caused side effects.
Botulinum toxin "Botox" is a natural toxin, which weakens the muscles when injected in very small amounts. It is currently approved and used for the treatment of various conditions involving abnormal muscle spasms, such as neck twisting (torticollis), twitching of the face (hemifacial spasm) or eyes (blepharospasm), headaches, muscles stiffness following strokes, and it has also been used cosmetically for wrinkle removal.
Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been tried, initial results showing that it is safe and effective. The injections generally take one week to start working and 2 weeks for a full effect, which lasts on average 12-16 weeks, and slowly wear off. The injections are generally repeated every 3-4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo armPlacebo arm |
| botulinum toxin type A | Active comparator | Drug: Botulinum toxin type AActive arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Patients between the ages of 18 and 80 years old with a diagnosis of bruxism, based on the standard criteria.
- 2. If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, or otherwise be incapable of pregnancy, or have practiced a method of contraception (hormonal contraceptives, spermicidal barrier, intrauterine device, partner sterility) at least one month prior to study entry. Any female of childbearing age will have a urine pregnancy test one week prior to the treatment (visit 2).
- 3. Ability of the patient or guardian to sign and understand informed consent.
- 4. Ability to follow and comply with study directions.
Key exclusion criteria (12 listed)
- 1. Coexistence of active psychosis, other active psychiatric disease or cognitive impairment.
- 2. Coexistence of serious co-morbid conditions.
- 3. Exposure to any botulinum toxin preparation within the past 6 months.
- 4. Participation in another experimental therapeutic protocol within 30 days.
- 5. Any medical condition in which the administration of botulinum toxin is contraindicated, including myasthenia gravis, amyotrophic lateral sclerosis or other neuromuscular diseases.
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 type AAlso: Botulinum toxin type A (Botox)Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally. | Drug | botulinum toxin type A |
| Placebo armPlacebo comparator | Drug | Placebo |
Primary outcome
Bruxism Questionnaire Baseline and at Week 4
Time frame: baseline versus week 4
Baseline assessments included a bruxism questionnaire with a modified quantifiable portion [Lavigne G. with permission]. This is compared to week 4 assessments. The bruxism questionnaire consists of 8 questions. Each question can be scored between 0-3 points for a total possible scoring of 24 points. The minimum score is 0. The maximum score if 24. A score of 3 or less means non-temporomandibular disorder. A score of 4 or more means temporomandibular disorder.
4 secondary outcomes
Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4
Time frame: Baseline to week 4
Clinical Global Impression (CGI)
Time frame: baseline versus week 4
Visual Analog Scale of Change (VAS)-Pain Scale
Time frame: baseline versus week 4
Visual Analog Scale of Change (VAS)-Pain
Time frame: Baseline versus week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
William G Ondo, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin type A in people with Bruxism, run by Baylor College of Medicine at 1 site in United States.
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 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: finished, as of the sponsor's last update on 18 Jun 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bruxism Questionnaire Baseline and at Week 4 (time frame: baseline versus week 4). 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 18 Jun 2023.