Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis
Primary Purpose
Arthritis
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Dexamethasone
Isotonic saline
Sponsored by

About this trial
This is an interventional treatment trial for Arthritis focused on measuring TMJ, corticosteroids, osteoarthritis, arthrocentesis, pain
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
Sites / Locations
- University Medical Centre Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Dexamethasone
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline in TMJ pain at 24 weeks
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
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.
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).
Full Information
NCT ID
NCT01275014
First Posted
November 29, 2010
Last Updated
January 11, 2011
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT01275014
Brief Title
Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis
Official Title
Corticosteroids as Additive in Arthrocentesis of the Temporomandibular Joint: Double Blind, Randomised Controlled Trial of Effectiveness.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
TMJ, corticosteroids, osteoarthritis, arthrocentesis, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Dexamethasone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
1 ml of 20mg/ml solution was applied once, following the arthrocentesis procedure of the TMJ
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
1 ml of isotonic saline was applied once, following the arthrocentesis procedure of the TMJ
Primary Outcome Measure Information:
Title
Change from Baseline in TMJ pain at 24 weeks
Description
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".
Time Frame
0 (T0), and at 1 (T1), 3 (T2) and 24 (T3) weeks.
Title
Change from Baseline in Maximal interincisal opening at 24 weeks
Description
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.
Time Frame
T0, and at T1, T2 and T3.
Secondary Outcome Measure Information:
Title
Change from baseline of mandibular function impairment at 24 weeks.
Description
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).
Time Frame
T0, T1, T2 and T3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Huddleston Slater, PhD
Organizational Affiliation
University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22157100
Citation
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.
Results Reference
derived
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Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis
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