Status:
COMPLETED
Study of the Safety and Efficacy of Botox in Bruxism
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Allergan
Conditions:
Bruxism
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 awak...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00908050
Start Date
April 1 2009
End Date
September 1 2011
Last Update
June 18 2023
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030