Influences of Types of Skull Surgery on Temporomandibular Joint Performance

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01966939
First received: October 17, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  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 ] [ 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)
Groups/Cohorts
Surgery
Craniotomy or Craniectomy
Control
age, gender and teeth condition matched

  Eligibility

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.

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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov 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:
craniotomy
craniectomy
temporalis
TMJ
mastication
QoL

ClinicalTrials.gov processed this record on October 21, 2014