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Study of the Safety and Efficacy of Botox in Bruxism

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Baylor College of Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908050
First Posted: May 25, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by:
Baylor College of Medicine
  Purpose
The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.

Condition Intervention Phase
Bruxism Drug: Botulinum toxin type A Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF BOTULINUM TOXIN TYPE A (BOTOX) IN BRUXISM

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

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

Estimated Enrollment: 32
Study Start Date: April 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo arm
Drug: Botulinum toxin type A

week 1: the patient will undergo the following: a. physical examination; b. sleep questionnaire c. bruxism questionnaire to establish a clinical diagnosis of bruxism; d. headache questionnaire; e. Clinical Global Improvement scale; f. masseter muscle measurement; g. anxiety questionnaire; h. demographic questionnaire;

week 2: The patient undergoes a polysomnogram (sleep study). The patient will spend one night (10:30pm-8:00am or until spontaneous awakening) in a sleep lab. During the sleep study, the following parameters will be recorded: electroencephalogram, electro-oculogram, upper airway resistance, heart rate, muscle activity; upper airway resistance,masseter muscles bilaterally. All recordings are performed using surface electrodes (self-adhesive to the skin), none of them invasive.

Study visit 3 (week 3): Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.

Other Name: Botox
Active Comparator: botulinum toxin type A
Active arm
Drug: Botulinum toxin type A

week 1: the patient will undergo the following: a. physical examination; b. sleep questionnaire c. bruxism questionnaire to establish a clinical diagnosis of bruxism; d. headache questionnaire; e. Clinical Global Improvement scale; f. masseter muscle measurement; g. anxiety questionnaire; h. demographic questionnaire;

week 2: The patient undergoes a polysomnogram (sleep study). The patient will spend one night (10:30pm-8:00am or until spontaneous awakening) in a sleep lab. During the sleep study, the following parameters will be recorded: electroencephalogram, electro-oculogram, upper airway resistance, heart rate, muscle activity; upper airway resistance,masseter muscles bilaterally. All recordings are performed using surface electrodes (self-adhesive to the skin), none of them invasive.

Study visit 3 (week 3): Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.

Other Name: Botox

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908050


Contacts
Contact: William G Ondo, MD 713-798-7438 wondo@bcm.edu
Contact: Toby Yaltho, MD 713-798-7438 yaltho@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: William G Ondo, MD    713-798-7438    wondo@bcm.edu   
Principal Investigator: William G Ondo, MD         
Sponsors and Collaborators
Baylor College of Medicine
Allergan
Investigators
Principal Investigator: William G Ondo, MD Baylor College of Medicine
  More Information

Responsible Party: William G. Ondo, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00908050     History of Changes
Other Study ID Numbers: H-22737
First Submitted: May 21, 2009
First Posted: May 25, 2009
Last Update Posted: October 12, 2017
Last Verified: September 2010

Keywords provided by Baylor College of Medicine:
bruxism, botulinum toxin, sleep study

Additional relevant MeSH terms:
Bruxism
Tooth Diseases
Stomatognathic Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents