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Influences of Types of Skull Surgery on Temporomandibular Joint Performance

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: NCT01966939
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 22, 2013
Last Update Posted : October 22, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date October 17, 2013
First Posted Date October 22, 2013
Last Update Posted Date October 22, 2013
Study Start Date June 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 17, 2013)
  • Jaw movement [ Time Frame: within 1 year after surgery ]
  • Jaw Functional Limitation Scale [ Time Frame: within 1 year after surgery ]
  • Bite force [ Time Frame: within 1 year after surgery ]
  • WHOQOL-BREF Taiwanese Version [ Time Frame: within 1 year after surgery ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Influences of Types of Skull Surgery on Temporomandibular Joint Performance
Official Title Influences of Types of Skull Surgery on Temporomandibular Joint Performance
Brief Summary

There are two purposes on this study:

- to investigate the effect of craniectomy and craniotomy on temporomandibular joint TMJ) movement, function and quality of life (QoL)

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population subjects received craniotomy or craniectomy and age, gender and teeth condtion matched control subjects.
Condition
  • Craniotomy
  • Craniectomy
Intervention Not Provided
Study Groups/Cohorts
  • Surgery
    Craniotomy or Craniectomy
  • Control
    age, gender and teeth condition matched
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 17, 2013)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • over 20 years old
  • post-craniotomy or post-craniectomy
  • able to follow order

Exclusion Criteria:

  • severe orofacial injury
  • severe teeth loss
  • significant changes of occlusion
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01966939
Other Study ID Numbers 201106049RC
UN101-005 ( Other Grant/Funding Number: NTUH )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jau-Yih Tsauo, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date October 2013