Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT00908050
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00908050
Study Brief:
Protocol Section:
NCT00908050