Study of the Safety and Efficacy of Botox in Bruxism

NCT ID: NCT00908050

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-09-30

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.

Conditions

Bruxism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo arm

Group Type: PLACEBO_COMPARATOR

Placebo arm

Intervention Type: DRUG

Placebo comparator

botulinum toxin type A

Active arm

Group Type: ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type: DRUG

Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.

Interventions

Botulinum toxin type A

Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.

Intervention Type: DRUG

Placebo arm

Placebo comparator

Intervention Type: DRUG

Other Intervention Names

Botulinum toxin type A (Botox)

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.

• 12. Patients in whom it is felt that a major portion of overall sleep morbidity is not related to bruxism.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Joseph Jankovic

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William G Ondo, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-22737

Identifier Type: -

Identifier Source: org_study_id