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NCT01966939 Clinical Trial

Influences of Types of Skull Surgery on Temporomandibular Joint Performance

Craniotomy Clinical Trial

Official title:
Influences of Types of Skull Surgery on Temporomandibular Joint Performance

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01966939
Other study ID # 201106049RC
Secondary ID UN101-005
Status Recruiting
Phase N/A
First received October 17, 2013
Last updated October 17, 2013
Start date June 2012
Est. completion date December 2013

Study information
Verified date October 2013
Source National Taiwan University Hospital
Contact Jau-Yih Tsauo, PhD
Phone 886-2-33668130
Email jytsauo@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Jaw movement within 1 year after surgery No
Primary Jaw Functional Limitation Scale within 1 year after surgery No
Primary Bite force within 1 year after surgery No
Primary WHOQOL-BREF Taiwanese Version within 1 year after surgery No
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