Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis

NCT ID: NCT01275014

Last Updated: 2011-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-12-31

Brief 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.

Detailed Description

The arthrocentesis procedure was performed under local anaesthesia and took place in a closed operation room under controlled conditions. After marking the points for insertion of the needles, a first 18 gauge injection needle was inserted into the upper intra-articular space of the TMJ. Correct positioning of the needle was determined by injecting and aspirating saline. Subsequently, a second 18 gauge needle was inserted into the upper joint space about 8-10 mm anterior of the first needle. Correct positioning of the second needle was confirmed by allowing injected saline to leave the joint through the first needle. After positioning of the needles, one needle was connected to a medical infusion system to passively allow isotonic saline of 37 degrees Celsius to enter the upper joint compartment. The other needle was connected to an outflow tube to allow the fluid to exit the joint. In about 15 minutes, approximately 300 ml saline passively flushed the joint. Thereafter, the inflow was stopped and the prepared syringe (see randomisation procedure) that contained either dexamethasone or saline was connected to the inflow needle. In this way, either 1 cc of dexamethasone or an equal amount of saline was washed through the joint in a blinded way. At the end of the procedure, the needles were removed from the joint, and after hemostasis by compression (if necessary) the skin overlying the TMJ was covered with a sterile band aid.

All patients were then instructed to avoid TMJ loading by following a soft diet for at least two weeks, then gradually advancing to more tough food. In addition, ibuprofen 600 mg 3dd was prescribed for the first 2-5 days to reduce any postoperative pain. All procedures were performed by one surgeon.

Follow up visits were scheduled after 1 (T1), 3 (T2) and 24 (T3) weeks.

Conditions

Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Isotonic saline

Intervention Type: DRUG

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

Dexamethasone

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

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

Interventions

Dexamethasone

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

Intervention Type: DRUG

Isotonic saline

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Pain localized in one of the TMJs (TMJ arthralgia).

Exclusion Criteria

• No significant relief of pain within 10 minutes after anaesthesia (injecting 0,1 ml articaine 40 mg/ml) of the TMJ
• Past history of open surgery in the affected joint
• Known polyarthritis (mostly rheumatoid arthritis)
• Age under 18 yrs
• Ankylosis of the TMJ
• Reported pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

University Medical Center Groningen

Principal Investigators

James Huddleston Slater, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center

Locations

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

References

Huddleston Slater JJ, Vos LM, Stroy LP, Stegenga B. Randomized trial on the effectiveness of dexamethasone in TMJ arthrocentesis. J Dent Res. 2012 Feb;91(2):173-8. doi: 10.1177/0022034511431260. Epub 2011 Dec 8.

Reference Type: DERIVED

PMID: 22157100 (View on PubMed)

Other Identifiers

14439

Identifier Type: OTHER

Identifier Source: secondary_id

UMCG_KCHIR_01

Identifier Type: -

Identifier Source: org_study_id