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A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01524913
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota
University of Cincinnati
University of Pennsylvania
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University

Tracking Information
First Submitted Date  ICMJE January 29, 2012
First Posted Date  ICMJE February 2, 2012
Results First Submitted Date  ICMJE January 12, 2017
Results First Posted Date  ICMJE May 5, 2017
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
Change in Pain Between Baseline and Month 1 Scores [ Time Frame: Baseline (preoperation), Month 1 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
Pain [ Time Frame: 3 months ]
Pain will be assessed preoperatively and again at 1 and 3 months using a visual analogue scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 [ Time Frame: Baseline (preoperation), Month 1, Month 3 ]
    Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain.
  • Jaw Function Limitation Scale (JFLS) Score [ Time Frame: Month 1 ]
    The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of "no" are scored as "0" and responses of "yes" are scored as "1". The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8).
  • Jaw Function Limitation Scale (JFLS) Score [ Time Frame: Month 3 ]
    The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of "no" are scored as "0" and responses of "yes" are scored as "1". The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
Function [ Time Frame: 3 months ]
Range of motion will be assessed preoperatively and again at 1 and 3 months using a millimeter ruler for maximum incisal opening and a jaw function limitation scale for other functional activities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
Official Title  ICMJE A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction
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.

Detailed Description This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Temporomandibular Joint Dysfunction
  • Pain
  • Arthrocentesis
Intervention  ICMJE
  • Drug: Hyaluronic acid
    1 cc hyalgan to be injected into superior joint space
  • Drug: Corticosteroid
    1cc celestone (6 mg/cc) will be injected into the joint space
  • Drug: Lactated Ringers
    1 cc lactated ringers solution will be injected into the joint space
Study Arms  ICMJE
  • Experimental: Hyaluronic acid
    Intervention: Drug: Hyaluronic acid
  • Active Comparator: Corticosteroid
    Intervention: Drug: Corticosteroid
  • Placebo Comparator: Saline
    Intervention: Drug: Lactated Ringers
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2017)
102
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2012)
330
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01524913
Other Study ID Numbers  ICMJE IRB00018682
Arthrocentesis ( Other Identifier: Other )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE
  • University of California, Los Angeles
  • Oregon Health and Science University
  • University of Minnesota
  • University of Cincinnati
  • University of Pennsylvania
Investigators  ICMJE
Principal Investigator: Gary F Bouloux, MD, DDS Emory University
PRS Account Emory University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP