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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 10 May 2023

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Sleep bruxism
  • Focus Therapeutic Use

    • Most Recent Events

    • 12 Feb 2018 New trial record
    • 17 Jan 2018 Primary endpoint efficacy as assessed by clinical global impressions (CGIs)) has been met, according to results published in the Neurology.
    • 17 Jan 2018 Results assessing safety and efficacy of onabotulinum toxin-A (BoNT-A) injections into the masseter and temporalis muscles in patients with symptomatic sleep bruxism, were published in the Neurology.

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