CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Botulinum toxin type A +1 moredrug
Likely dose
Botulinum toxin type A 60 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00908050
NCT00908050Phase 4Completed
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Double-blind, Placeboa-controlled, Randomized Clinical Trial of the Safety and Efficacy of Botulinum Toxin (BOTOX) in Bruxism.

Baylor College of Medicine·interventional·Posted May 25, 2009·Updated Jun 18, 2023

In Brief

A Phase 4 clinical trial evaluating Botulinum toxin type A and Placebo arm for Bruxism. Completed, enrolled 23 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBruxism
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2009
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.1 years ago

Interventions

Botulinum toxin type Adrug

Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.

Placebo armdrug

Placebo comparator