A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction
2 other identifiers
interventional
102
1 country
5
Brief Summary
The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function. The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2012
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 29, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
May 5, 2017
CompletedMay 5, 2017
March 1, 2017
3.9 years
January 29, 2012
January 12, 2017
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pain Between Baseline and Month 1 Scores
The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.
Baseline (preoperation), Month 1
Secondary Outcomes (3)
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Baseline (preoperation), Month 1, Month 3
Jaw Function Limitation Scale (JFLS) Score
Month 1
Jaw Function Limitation Scale (JFLS) Score
Month 3
Study Arms (3)
Hyaluronic acid
EXPERIMENTALCorticosteroid
ACTIVE COMPARATORSaline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age greater than 18 years
- arthralgia of one or both temporomandibular joints
- Wilkes II to IV internal derangement of the symptomatic joint OR
- limited opening of \<35 mm
You may not qualify if:
- myofascial pain as the primary source of pain
- cervical pain as the primary source of pain
- systemic arthropathy
- fibromyalgia
- use of NSAIDS within 48 hours
- allergy to study medications
- edentulous subjects
- pregnancy or breast feeding
- current physical therapy, muscle relaxants or antiseizure medications
- current use of a splint issued within last 12 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- University of California, Los Angelescollaborator
- Oregon Health and Science Universitycollaborator
- University of Minnesotacollaborator
- University of Cincinnaticollaborator
- University of Pennsylvaniacollaborator
Study Sites (5)
University California Los Angeles
Los Angeles, California, 90024, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Cinncinati
Cinncinati, Ohio, 45219, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short-Term Reduction of Temporomandibular Joint Pain After Arthrocentesis? Part 1. J Oral Maxillofac Surg. 2017 Jan;75(1):52-62. doi: 10.1016/j.joms.2016.08.006. Epub 2016 Aug 20.
PMID: 27632069RESULTBouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short Term for Improving Function and Quality of Life After Arthrocentesis? Part 2. J Oral Maxillofac Surg. 2017 Jan;75(1):63-72. doi: 10.1016/j.joms.2016.08.008. Epub 2016 Aug 20.
PMID: 27632067RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Bouloux, MD, DDS
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Gary F Bouloux, MD, DDS
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- National PI
Study Record Dates
First Submitted
January 29, 2012
First Posted
February 2, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
May 5, 2017
Results First Posted
May 5, 2017
Record last verified: 2017-03