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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396694
First Posted: July 19, 2011
Last Update Posted: February 17, 2016
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.
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
  Purpose
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 Intervention
Psychological Predictors Other: Questionnaire

Study Type: Observational
Study Design: 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

Further study details as provided by Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 105
Study Start Date: June 2009
Study Completion Date: December 2015
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
all
All patients requiring arthroscopy or arthroplasty
Other: Questionnaire
Questionnaire

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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


Locations
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 Submitted: July 8, 2011
First Posted: July 19, 2011
Last Update Posted: February 17, 2016
Last Verified: February 2016


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