Clinical Trial: Study of the Safety and Efficacy of Botox in Bruxism

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF BOTULINUM TOXIN TYPE A (BOTOX) IN BRUXISM

Brief Summary: The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.

Detailed Summary:

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.

Sponsor: Baylor College of Medicine

Current Primary Outcome: Age and maximum masseter voluntary contractions (MVC) [ Time Frame: baseline for the treatment versus placebo groups ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Baylor College of Medicine

Dates:
Date Received: May 21, 2009
Date Started: April 2009
Date Completion: July 2012
Last Updated: June 23, 2011
Last Verified: September 2010