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An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery

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: NCT01396694
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction will complete a psychological questionnaire prior to surgery. The 3 month outcomes including pain and function will be examined using regression analysis to identify psychological variables that may predict outcomes.

Condition or disease Intervention/treatment
Psychological Predictors Other: Questionnaire

Study Design

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 4 Study of the Influence of Psychological Factors on the Outcomes Following Arthroscopy and Arthroplasty for Temporomandibular Joint Dysfunction
Study Start Date : June 2009
Primary Completion Date : December 2012
Study Completion Date : December 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
All patients requiring arthroscopy or arthroplasty
Other: Questionnaire

Outcome Measures

Primary Outcome Measures :
  1. Pain [ Time Frame: 3 months ]
    Pain will be recorded in a site specific matter (left and right TMJ) using a visual analogue scale

Secondary Outcome Measures :
  1. Function [ Time Frame: 3 months ]
    Function will be measured using the jaw function limitation scale which will assess overall jaw and masticatory function with a short well validated questionnaire

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
18 yrs

Inclusion Criteria:

  • require arthroscopy or arthroplasty

Exclusion Criteria:

  • age less than 18 yrs
  • prior surgery
  • unable to give informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396694

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
More Information

Responsible Party: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, PI, Emory University
ClinicalTrials.gov Identifier: NCT01396694     History of Changes
Other Study ID Numbers: IRB00061869
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016