ArthritisPhase 4NCT01275014
Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis
A Phase 4 study testing Dexamethasone and Isotonic saline in people with Arthritis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The aim is to compare the effectiveness of corticosteroid administration (dexamethasone) with a placebo (saline), following arthrocentesis of for the temporomandibular joint (TMJ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Dexamethasone and Isotonic saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain localized in one of the TMJs (TMJ arthralgia).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Groningen
Groningen, Provincie Groningen, 9700 RB
About this study
Official title: Corticosteroids as Additive in Arthrocentesis of the Temporomandibular Joint: Double Blind, Randomised Controlled Trial of Effectiveness.
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.
Read the 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
- Being tested
- Dexamethasone, Isotonic saline
- Keywords
- TMJ, corticosteroids, osteoarthritis, arthrocentesis, pain
- Medical subject headings
- Arthritis, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
1 ml of 20mg/ml solution was applied once, following the arthrocentesis procedure of the TMJ
Isotonic salineDrug
1 ml of isotonic saline was applied once, following the arthrocentesis procedure of the TMJ
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Isotonic saline |
| Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 0 (T0), and at 1 (T1), 3 (T2) and 24 (T3) weeks.
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.
Measured: T0, and at T1, T2 and T3.
Secondary outcomes (1)
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).
Measured: T0, T1, T2 and T3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startDec 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- James Huddleston Slater, PhD, Principal investigator, University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275014
- Sponsor's protocol ID
- UMCG_KCHIR_01
- Other IDs
- 14439
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22157100
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids as Additive in Arthrocentesis of the Temporomandibular Joint: Double Blind, Randomised Controlled Trial of Effectiveness.
- ClinicalTrials.gov ID
- NCT01275014
- Acronym / sponsor ID
- UMCG_KCHIR_01
- Conditions
- Arthritis
- Keywords
- TMJ, corticosteroids, osteoarthritis, arthrocentesis, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Isotonic saline |
| Dexamethasone | Experimental | Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pain localized in one of the TMJs (TMJ arthralgia).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone1 ml of 20mg/ml solution was applied once, following the arthrocentesis procedure of the TMJ | Drug | Dexamethasone |
| Isotonic saline1 ml of isotonic saline was applied once, following the arthrocentesis procedure of the TMJ | Drug | Placebo |
Primary outcome
Change from Baseline in TMJ pain at 24 weeks
Time frame: 0 (T0), and at 1 (T1), 3 (T2) and 24 (T3) 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
Time frame: T0, and at T1, T2 and T3.
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.
1 secondary outcome
Change from baseline of mandibular function impairment at 24 weeks.
Time frame: T0, T1, T2 and T3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
- Derived from this study: PubMed 22157100Huddleston 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.
Related trials for Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Huddleston Slater, PhD principal investigator
University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Isotonic saline in people with Arthritis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in TMJ pain at 24 weeks (time frame: 0 (T0), and at 1 (T1), 3 (T2) and 24 (T3) weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2011.