Study of the Safety and Efficacy of Botox in Bruxism

Double-blind, Placeboa-controlled, Randomized Clinical Trial of the Safety and Efficacy of Botulinum Toxin (BOTOX) in Bruxism.

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

Study Overview

• Status: Completed
• Conditions: Bruxism
• Intervention / Treatment: Drug: Placebo arm; Drug: Botulinum toxin type A

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo arm	Drug: Placebo arm; Placebo comparator
Active Comparator: botulinum toxin type A; Active arm	Drug: 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.; Other Names: Botulinum toxin type A (Botox)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bruxism Questionnaire Baseline and at Week 4	Baseline assessments included a bruxism questionnaire with a modified quantifiable portion [Lavigne G. with permission]. This is compared to week 4 assessments. The bruxism questionnaire consists of 8 questions. Each question can be scored between 0-3 points for a total possible scoring of 24 points. The minimum score is 0. The maximum score if 24. A score of 3 or less means non-temporomandibular disorder. A score of 4 or more means temporomandibular disorder.	baseline versus week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4	Baseline assessments included HIT-6 questionnaire. This is compared to week 4 assessments. The Headache Impact Test consists of 6 questions. Each question can be scored between 6 to 13 points for a possible total of 78 points. A total score of 50 or more means the patient has migraines. A score of 49 or less means the patient has headaches, not migraines. The minimum score if 36. The maximum score is 78 points.	Baseline to week 4
Clinical Global Impression (CGI)	With this scale the clinical evaluates the patient and gives the patient a single score based off of the evaluation. The score given can be between 1 and 7 where 1 means the patient is normal and 7 means the patient is amongst the most severely ill. The minimum score if 1. The maximum score is 7.	baseline versus week 4
Visual Analog Scale of Change (VAS)-Pain Scale	Visual Analog scale of change (VAS) (0-100) comparing delta of pre-versus post-injection.The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum score if 100.	baseline versus week 4
Visual Analog Scale of Change (VAS)-Pain	The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum sore if 100.	Baseline versus week 4

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Allergan
• Investigators: Principal Investigator: William G Ondo, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: May 21, 2009
• First Submitted That Met QC Criteria: May 22, 2009
• First Posted (Estimated): May 25, 2009

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: bruxism, botulinum toxin, sleep study
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Bruxism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: H-22737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO