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Study of the Safety and Efficacy of Botox in Bruxism

NCT00908050 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-06-18

Study results available
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Summary

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

Conditions

  • Bruxism

Interventions

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.

DRUG

Placebo arm

Placebo comparator

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • William G Ondo, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00908050 on ClinicalTrials.gov