Phase 4 N=23 Randomized Double-blind Treatment

Study of the Safety and Efficacy of Botox in Bruxism

Bruxism

Bottom Line

View on ClinicalTrials.gov: NCT00908050 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Bruxism Questionnaire Baseline and at Week 4 — 19.4; 16.1; 24.0; 24.0 units on a scale — p=0.0394

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Botulinum toxin type A (Drug); Placebo arm (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Bruxism Questionnaire Baseline and at Week 4	19.4; 16.1; 24.0; 24.0	0.0394 sig
SECONDARY Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4	57.8; 52.1; 59.2; 51.2	—
SECONDARY Clinical Global Impression (CGI)	3; 4; 3; 2	—
SECONDARY Visual Analog Scale of Change (VAS)-Pain Scale	47.3; 64.5; 45.8; 48.6	—
SECONDARY Visual Analog Scale of Change (VAS)-Pain	47.3; 44.2; 48.6; 65	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00908050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.