Clinical trial NCT00908050: Study of the Safety and Efficacy of Botox in Bruxism
Official title: Double-blind, Placeboa-controlled, Randomized Clinical Trial of the Safety and Efficacy of Botulinum Toxin (BOTOX) in Bruxism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bruxism
Keywords: bruxism, botulinum toxin, sleep study
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2009-05-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bruxism Questionnaire Baseline and at Week 4
timeFrame: baseline versus week 4
Secondary outcomes:
measure: Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4
timeFrame: Baseline to week 4
measure: Clinical Global Impression (CGI)
timeFrame: baseline versus week 4
measure: Visual Analog Scale of Change (VAS)-Pain Scale
timeFrame: baseline versus week 4
measure: Visual Analog Scale of Change (VAS)-Pain
timeFrame: Baseline versus week 4
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: William G Ondo, MD
role: PRINCIPAL_INVESTIGATOR
References: