Bruxism
Conditions
Keywords
bruxism, botulinum toxin, sleep study
Brief summary
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.
Interventions
DRUGBotulinum toxin type A
Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.
DRUGPlacebo arm
Placebo comparator
Sponsors
Allergan
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bruxism Questionnaire Baseline and at Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4 | Baseline to 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. |
| Clinical Global Impression (CGI) | baseline versus week 4 | 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. |
| Visual Analog Scale of Change (VAS)-Pain Scale | baseline versus week 4 | 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. |
| Visual Analog Scale of Change (VAS)-Pain | Baseline versus week 4 | 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. |
Countries
United States
Participant flow
Recruitment details
Thirty-one subjects were recruited but eight were excluded: 3 prior to randomization/PSG (withdrew consent), 5 before randomization/after PSG (3 for lack of bruxism on PSG, 2 for severe obstructive sleep apnea on PSG with an AHI \> 30 / hr).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo arm
We performed a double blind, placebo-controlled parallel trial of BoNT-A (Botox®, Allergan) for bruxism, followed by an open label extension. Patients were recruited from the Baylor College of Medicine (BCM) Movement Disorders Clinic from April 2009 to March 2011. | 10 |
| Botulinum Toxin Type A Active arm
We performed a double blind, placebo-controlled parallel trial of BoNT-A (Botox®, Allergan) for bruxism, followed by an open label extension. Patients were recruited from the Baylor College of Medicine (BCM) Movement Disorders Clinic from April 2009 to March 2011. | 13 |
| Total | 23 |
Baseline characteristics
| Characteristic | Placebo | Botulinum Toxin Type A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 13 Participants | 23 Participants |
| Region of Enrollment United States | 10 participants | 13 participants | 23 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 10 | 13 / 13 |
| serious Total, serious adverse events | 0 / 10 | 0 / 13 |
Outcome results
Primary
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.
Time frame: baseline versus week 4
Population: Bruxism questionnaire comparison at Week 4 in placebo versus active treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Bruxism Questionnaire Baseline and at Week 4 | 19.4 units on a scale | Standard Deviation 13.2 |
| Botulinum Toxin Type A at Baseline | Bruxism Questionnaire Baseline and at Week 4 | 16.1 units on a scale | Standard Deviation 4.1 |
| Placebo Arm at Week 4 | Bruxism Questionnaire Baseline and at Week 4 | 24.0 units on a scale | Standard Deviation 5.4 |
| Botulinum Toxin Type A at Week 4 | Bruxism Questionnaire Baseline and at Week 4 | 24.0 units on a scale | Standard Deviation 6.9 |
Comparison: The averaged data calculated from three nights in each recording period for each subject will be submitted to statistical analysis. Descriptive and non-parametric statistics will be used for the secondary end-points.p-value: 0.0394Chi-squared
Secondary
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.
Time frame: baseline versus week 4
Population: CGI questionnaire comparison at Week 4 in placebo versus active treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Clinical Global Impression (CGI) | 3 units on a scale | Standard Deviation 0.05 |
| Botulinum Toxin Type A at Baseline | Clinical Global Impression (CGI) | 4 units on a scale | Standard Deviation 0.05 |
| Placebo Arm at Week 4 | Clinical Global Impression (CGI) | 3 units on a scale | Standard Deviation 0.05 |
| Botulinum Toxin Type A at Week 4 | Clinical Global Impression (CGI) | 2 units on a scale | Standard Deviation 0.05 |
Secondary
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.
Time frame: Baseline to week 4
Population: HIT-6 questionnaire comparison at Week 4 in placebo versus active treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4 | 57.8 units on a scale | Standard Deviation 9 |
| Botulinum Toxin Type A at Baseline | Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4 | 52.1 units on a scale | Standard Deviation 10.6 |
| Placebo Arm at Week 4 | Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4 | 59.2 units on a scale | Standard Deviation 9.1 |
| Botulinum Toxin Type A at Week 4 | Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4 | 51.2 units on a scale | Standard Deviation 11.4 |
Secondary
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.
Time frame: Baseline versus week 4
Population: VAS-pain questionnaire comparison at Week 4 in placebo versus active treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Visual Analog Scale of Change (VAS)-Pain | 47.3 units on a scale | Standard Deviation 15.5 |
| Botulinum Toxin Type A at Baseline | Visual Analog Scale of Change (VAS)-Pain | 44.2 units on a scale | Standard Deviation 14.3 |
| Placebo Arm at Week 4 | Visual Analog Scale of Change (VAS)-Pain | 48.6 units on a scale | Standard Deviation 13.6 |
| Botulinum Toxin Type A at Week 4 | Visual Analog Scale of Change (VAS)-Pain | 65 units on a scale | Standard Deviation 19.6 |
Secondary
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.
Time frame: baseline versus week 4
Population: VAS-pain scale questionnaire comparison at Week 4 in placebo versus active treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Visual Analog Scale of Change (VAS)-Pain Scale | 47.3 units on a scale | Standard Deviation 15.5 |
| Botulinum Toxin Type A at Baseline | Visual Analog Scale of Change (VAS)-Pain Scale | 64.5 units on a scale | Standard Deviation 17.8 |
| Placebo Arm at Week 4 | Visual Analog Scale of Change (VAS)-Pain Scale | 45.8 units on a scale | Standard Deviation 19.6 |
| Botulinum Toxin Type A at Week 4 | Visual Analog Scale of Change (VAS)-Pain Scale | 48.6 units on a scale | Standard Deviation 13.6 |