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Study of the Safety and Efficacy of Botox in Bruxism

Primary Purpose

Bruxism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo arm
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruxism focused on measuring bruxism, botulinum toxin, sleep study

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

botulinum toxin type A

Arm Description

Placebo arm

Active arm

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 21, 2009
Last Updated
June 15, 2023
Sponsor
Baylor College of Medicine
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00908050
Brief Title
Study of the Safety and Efficacy of Botox in Bruxism
Official Title
Double-blind, Placeboa-controlled, Randomized Clinical Trial of the Safety and Efficacy of Botulinum Toxin (BOTOX) in Bruxism.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism
Keywords
bruxism, botulinum toxin, sleep study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm
Arm Title
botulinum toxin type A
Arm Type
Active Comparator
Arm Description
Active arm
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Botulinum toxin type A (Botox)
Intervention Description
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
Intervention Name(s)
Placebo arm
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Bruxism Questionnaire Baseline and at Week 4
Description
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.
Time Frame
baseline versus week 4
Secondary Outcome Measure Information:
Title
Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4
Description
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.
Time Frame
Baseline to week 4
Title
Clinical Global Impression (CGI)
Description
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.
Time Frame
baseline versus week 4
Title
Visual Analog Scale of Change (VAS)-Pain Scale
Description
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.
Time Frame
baseline versus week 4
Title
Visual Analog Scale of Change (VAS)-Pain
Description
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.
Time Frame
Baseline versus week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William G Ondo, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of the Safety and Efficacy of Botox in Bruxism

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