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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo arm |
|
| botulinum toxin type A | Active Comparator | Active arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline versus week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William G Ondo, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo arm |
| FG001 | Botulinum Toxin Type A | botulinum toxin type A (BOTOX) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Thirty-one subjects were recruited, eight were excluded: 3 (withdrew consent), 5 after PSG (3 for lack of bruxism on PSG, 2 severe OSA on PSG with an AHI > 30 / hr). 19 females were randomized. 21 reported some temporal-mandibular pain. 13 randomized to BoNT-A and 10 randomized to placebo & completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Bruxism questionnaire comparison at Week 4 in placebo versus active treatment group. | Posted | Mean | Standard Deviation | units on a scale | baseline versus week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion [Lavigne G. with permission]. Additional scales included the Headache Impact Test-6 24, total Pittsburgh Sleep Quality Index 25, Epworth Sleepiness Scale 26, and Self-Rated Anxiety Scale. 27 Subjects then underwent a baseline polysomnogram (PSG) and were excluded if no bruxism was identified, using standard criteria. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| temporal-mandibular pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Ondo, MD | Baylor College of Medicine/Houston Methodist | 713-363-8390 | wondo@houstonmethodist.org |
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| ID | Term |
|---|---|
| D002012 | Bruxism |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Placebo arm | Drug | Placebo comparator |
|
| 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. | 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. | 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. | Baseline versus week 4 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Botulinum Toxin Type A at Baseline | Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion [Lavigne G. with permission]. |
| OG002 | Placebo Arm at Week 4 | Baseline assessments included a bruxism questionnaire with a modified quantifiable portion [Lavigne G. with permission]. |
| OG003 | Botulinum Toxin Type A at Week 4 | Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion [Lavigne G. with permission]. |
|
|
|
| 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. | HIT-6 questionnaire comparison at Week 4 in placebo versus active treatment group. | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 4 |
|
|
|
| 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. | CGI questionnaire comparison at Week 4 in placebo versus active treatment group. | Posted | Mean | Standard Deviation | units on a scale | baseline versus week 4 |
|
|
|
| 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. | VAS-pain scale questionnaire comparison at Week 4 in placebo versus active treatment group. | Posted | Mean | Standard Deviation | units on a scale | baseline versus week 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. | VAS-pain questionnaire comparison at Week 4 in placebo versus active treatment group. | Posted | Mean | Standard Deviation | units on a scale | Baseline versus week 4 |
|
|
|
| 0 |
| 10 |
| 8 |
| 10 |
| EG001 | Botulinum Toxin Type A | Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion [Lavigne G. with permission]. Additional scales included the Headache Impact Test-6 24, total Pittsburgh Sleep Quality Index 25, Epworth Sleepiness Scale 26, and Self-Rated Anxiety Scale. 27 Subjects then underwent a baseline polysomnogram (PSG) and were excluded if no bruxism was identified, using standard criteria. | 0 | 13 | 13 | 13 |
| cosmetic change in smile | General disorders | Systematic Assessment |
|
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |