NCT01275014

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
Last Updated

January 12, 2011

Status Verified

November 1, 2010

Enrollment Period

2 years

First QC Date

November 29, 2010

Last Update Submit

January 11, 2011

Conditions

Arthritis

Keywords

TMJcorticosteroidsosteoarthritisarthrocentesispain

Outcome Measures

Primary Outcomes (2)

  • 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".

    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.

    T0, and at T1, T2 and T3.

Secondary Outcomes (1)

  • Change from baseline of mandibular function impairment at 24 weeks.

    T0, T1, T2 and T3

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Isotonic saline

Dexamethasone

EXPERIMENTAL
Drug: Dexamethasone

Interventions

DexamethasoneDRUG

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

Dexamethasone
Isotonic salineDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 22157100DERIVED

MeSH Terms

Conditions

ArthritisOsteoarthritisPain

Interventions

DexamethasoneSodium Chloride

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • James Huddleston Slater, PhD

    University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2010

First Posted

January 12, 2011

Study Start

December 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 12, 2011

Record last verified: 2010-11

Locations

NL(1)