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A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction

NCT01524913 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2017-05-05

Study results available
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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.

Conditions

  • Temporomandibular Joint Dysfunction
  • Pain
  • Arthrocentesis

Interventions

DRUG

Hyaluronic acid

1 cc hyalgan to be injected into superior joint space

DRUG

Corticosteroid

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

DRUG

Lactated Ringers

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

Sponsors & Collaborators

Principal Investigators

  • Gary F Bouloux, MD, DDS · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524913 on ClinicalTrials.gov