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NCT00908050 · ClinicalTrials.gov registry record · Phase 4

Study of the Safety and Efficacy of Botox in Bruxism

A Phase 4 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 4
Development phase
23
Enrollment target

NCT00908050: Completed Phase 4 study, sponsored by Baylor College of Medicine.

NCT00908050 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00908050, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 4
Development phase
23 participants
Enrollment target

Study Summary

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

Primary Outcome

Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\]. This is compared to week 4 assessments. The bruxism questionnaire consists of 8 questions. Each question can be scored between 0-3 points for a total possible scoring of 24 points. The minimum score is 0. The maximum score if 24. A score of 3 or less means non-temporomandibular disorder. A score of 4 or more means temporomandibular disorder.

Interventions

  • DRUG Botulinum toxin type A
  • DRUG Placebo arm

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2009-04
Est. Completion 2011-09
Phase Phase 4
Baylor College of Medicine

616 total trials

What the finished NCT00908050 record still lists

NCT00908050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Botulinum toxin type A is the first listed.

NCT00908050 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00908050 about?

NCT00908050 is a clinical study titled "Study of the Safety and Efficacy of Botox in Bruxism". The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.

What is the current status of trial NCT00908050?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2009-04. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00908050?

The interventions under investigation include: Botulinum toxin type A (DRUG), Placebo arm (DRUG).

Who is sponsoring clinical trial NCT00908050?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00908050's enrollment target sits among peer trials

23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00908050, the US trial registry maintained by the National Library of Medicine. NCT00908050 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.