NCT01524913

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.

Conditions

• Temporomandibular Joint Dysfunction
• Pain
• Arthrocentesis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-12-01
• Completion: 2016-04-01
• First posted: 2012-02-02
• Last updated: 2017-05-05
• Results posted: 2017-05-05

Locations

5 sites across 1 country: United States