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Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis

NCT01275014 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2011-01-12

No results posted yet for this study

Summary

The aim is to compare the effectiveness of corticosteroid administration (dexamethasone) with a placebo (saline), following arthrocentesis of for the temporomandibular joint (TMJ). Twenty-eight participants with TMJ arthralgia, mainly related to osteoarthritis ae randomly assigned to two arms of a parallel double blind RCT. In both arms an arthrocentesis procedure is carried out, while a single dose intraarticular dexamethasone was delivered to participants in one arm. Saline was delivered in the other arm to serve as a control. Follow up visits were scheduled after 1, 3 and 24 weeks. During each visit TMJ pain (on a 100mm VAS) and joint stiffness (mouth opening in mm) are scored. Generalized estimating equations (GEE) are used for statistical analysis.

Conditions

Interventions

DRUG

Dexamethasone

1 ml of 20mg/ml solution was applied once, following the arthrocentesis procedure of the TMJ

DRUG

Isotonic saline

1 ml of isotonic saline was applied once, following the arthrocentesis procedure of the TMJ

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • James Huddleston Slater, PhD · University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

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 NCT01275014 on ClinicalTrials.gov