Study of the Safety and Efficacy of Botox in Bruxism - Full Text View

Sponsor:	Baylor College of Medicine
Collaborator:	Allergan
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00908050

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Botox

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	William G. Ondo, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00908050 History of Changes
Other Study ID Numbers:	H-22737
Study First Received:	May 21, 2009
Last Updated:	June 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

bruxism, botulinum toxin, sleep study

Additional relevant MeSH terms:

Bruxism
Tooth Diseases
Stomatognathic Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012