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NCT01524913 · ClinicalTrials.gov registry record · Phase 4
A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT01524913: Completed Phase 4 study, sponsored by Emory University.
NCT01524913 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 102 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01524913, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function. The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
Primary Outcome
The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.
Interventions
- DRUG Corticosteroid
- DRUG Lactated Ringers
- DRUG Hyaluronic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-04 |
| Phase | Phase 4 |
What the finished NCT01524913 record still lists
NCT01524913 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Corticosteroid is the first listed.
NCT01524913 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01524913 about?
NCT01524913 is a clinical study titled "A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction". The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function. The overall hypothesis for the study is that hyalgan will result in a 30% reduction i...
What is the current status of trial NCT01524913?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2012-01. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01524913?
The interventions under investigation include: Corticosteroid (DRUG), Lactated Ringers (DRUG), Hyaluronic acid (DRUG).
Who is sponsoring clinical trial NCT01524913?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01524913's enrollment target sits among peer trials
102 764th of 2000 higher than 1,235 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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