Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University Medical Centre Groningen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01275014
First received: November 29, 2010
Last updated: January 11, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Arthritis
Drug: Dexamethasone
Drug: Isotonic saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corticosteroids as Additive in Arthrocentesis of the Temporomandibular Joint: Double Blind, Randomised Controlled Trial of Effectiveness.

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Change from Baseline in TMJ pain at 24 weeks [ Time Frame: 0 (T0), and at 1 (T1), 3 (T2) and 24 (T3) weeks. ] [ Designated as safety issue: No ]
    Change over 24 weeks from baseline for TMJ pain at rest and during mandibular movements. Measured by a 100 mm Visual Analogue Scale (VAS), limited by "no pain" and "worst pain imaginable".

  • Change from Baseline in Maximal interincisal opening at 24 weeks [ Time Frame: T0, and at T1, T2 and T3. ] [ Designated as safety issue: No ]
    Change over 24 weeks from baseline maximal interincisal opening at rest and during mandibular movements . Measured in mm between the incisal edges of the center incisors.


Secondary Outcome Measures:
  • Change from baseline of mandibular function impairment at 24 weeks. [ Time Frame: T0, T1, T2 and T3 ] [ Designated as safety issue: No ]
    Change over 24 weeks from baseline for the MFIQ. The MFIQ is a questionnaire assessing, on a five point scale, discomfort while performing mandibular functions and during eating of food with different consistencies (range of 0 - 68).


Enrollment: 28
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Isotonic saline
1 ml of isotonic saline was applied once, following the arthrocentesis procedure of the TMJ
Other Name: Isotonic Saline
Experimental: Dexamethasone Drug: Dexamethasone
1 ml of 20mg/ml solution was applied once, following the arthrocentesis procedure of the TMJ
Other Name: Dexamethasone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275014

Locations
Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: James Huddleston Slater, PhD University Medical Center
  More Information

No publications provided

Responsible Party: JJR Huddleston Slater, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01275014     History of Changes
Other Study ID Numbers: UMCG_KCHIR_01, 14439
Study First Received: November 29, 2010
Last Updated: January 11, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
TMJ
corticosteroids
osteoarthritis
arthrocentesis
pain

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014