Study of the Safety and Efficacy of Botox in Bruxism
Information source: Baylor College of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bruxism
Intervention: Botulinum toxin type A (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s):
William G Ondo, MD, Principal Investigator, Affiliation: Baylor College of Medicine
Overall contact:
William G Ondo, MD, Phone: 713-798-7438, Email: wondo@bcm.edu
Summary
The purpose of this study is to determine whether botulinum toxin helps patients with
bruxism.
Clinical Details
Official title: DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF BOTULINUM TOXIN TYPE A (BOTOX) IN BRUXISM
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Age and maximum masseter voluntary contractions (MVC)
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
William G Ondo, MD, Phone: 713-798-7438, Email: wondo@bcm.edu
Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Octavian Adam, MD, Phone: 713-798-7438, Email: oadam@bcm.edu
William G Ondo, MD, Principal Investigator
Additional Information
Starting date: April 2009
Ending date: February 2010
Last updated: May 22, 2009
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