CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 102 enrolled
Drug / intervention
Hyaluronic acid +2 moredrug
Likely dose
Corticosteroid 6 mgfrom 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/NCT01524913
NCT01524913Phase 4Completed
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A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction

Emory University·interventional·Posted Feb 2, 2012·Updated May 5, 2017

In Brief

A Phase 4 clinical trial evaluating Hyaluronic acid, Corticosteroid, and 1 other intervention for Temporomandibular Joint Dysfunction and 2 related conditions. Completed, enrolled 102 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTemporomandibular Joint Dysfunction, Pain, Arthrocentesis
CountriesUnited States
CollaboratorsUniversity of California, Los Angeles, Oregon Health and Science University, University of Minnesota, University of Cincinnati, University of Pennsylvania

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2012
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.4 years ago

Interventions

Hyaluronic aciddrug

1 cc hyalgan to be injected into superior joint space

Corticosteroiddrug

1cc celestone (6 mg/cc) will be injected into the joint space

Lactated Ringersdrug

1 cc lactated ringers solution will be injected into the joint space