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Influences of Types of Skull Surgery on Temporomandibular Joint Performance

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01966939
Collaborator
(none)
80
Enrollment
1
Location
18
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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)
Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Influences of Types of Skull Surgery on Temporomandibular Joint Performance
    Study Start Date :
    Jun 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2013
    Anticipated Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Surgery

    Craniotomy or Craniectomy
    Control

    age, gender and teeth condition matched

    Outcome Measures

    Primary Outcome Measures

    1. Jaw movement [within 1 year after surgery]

    2. Jaw Functional Limitation Scale [within 1 year after surgery]

    3. Bite force [within 1 year after surgery]

    4. WHOQOL-BREF Taiwanese Version [within 1 year after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Jau-Yih Tsauo, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT01966939
    Other Study ID Numbers:
    • 201106049RC
    • UN101-005
    First Posted:
    Oct 22, 2013
    Last Update Posted:
    Oct 22, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by National Taiwan University Hospital
    craniotomy
    craniectomy
    temporalis
    TMJ
    mastication
    QoL

    Study Results

    No Results Posted as of Oct 22, 2013