Influences of Types of Skull Surgery on Temporomandibular Joint Performance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: October 17, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted

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)


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 ] [ Designated as safety issue: No ]
  • Jaw Functional Limitation Scale [ Time Frame: within 1 year after surgery ] [ Designated as safety issue: No ]
  • Bite force [ Time Frame: within 1 year after surgery ] [ Designated as safety issue: No ]
  • WHOQOL-BREF Taiwanese Version [ Time Frame: within 1 year after surgery ] [ Designated as safety issue: No ]

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)
Craniotomy or Craniectomy
age, gender and teeth condition matched


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01966939

Contact: Jau-Yih Tsauo, PhD 886-2-33668130

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jau-Yih Tsauo, PhD    886-2-33668130   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Jau-Yih Tsauo, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital Identifier: NCT01966939     History of Changes
Other Study ID Numbers: 201106049RC, UN101-005
Study First Received: October 17, 2013
Last Updated: October 17, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
QoL processed this record on November 27, 2015