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Influences of Types of Skull Surgery on Temporomandibular Joint Performance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01966939
First Posted: October 22, 2013
Last Update Posted: October 22, 2013
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):
National Taiwan University Hospital
  Purpose

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)


Condition
Craniotomy Craniectomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Influences of Types of Skull Surgery on Temporomandibular Joint Performance

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgery
Craniotomy or Craniectomy
Control
age, gender and teeth condition matched

  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:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects received craniotomy or craniectomy and age, gender and teeth condtion matched control subjects.
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
  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): NCT01966939


Contacts
Contact: Jau-Yih Tsauo, PhD 886-2-33668130 jytsauo@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jau-Yih Tsauo, PhD    886-2-33668130    jytsauo@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jau-Yih Tsauo, PhD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01966939     History of Changes
Other Study ID Numbers: 201106049RC
UN101-005 ( Other Grant/Funding Number: NTUH )
First Submitted: October 17, 2013
First Posted: October 22, 2013
Last Update Posted: October 22, 2013
Last Verified: October 2013

Keywords provided by National Taiwan University Hospital:
craniotomy
craniectomy
temporalis
TMJ
mastication
QoL