NCT01966939

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

October 17, 2013

Last Update Submit

October 17, 2013

Conditions

CraniotomyCraniectomy

Keywords

craniotomycraniectomytemporalisTMJmasticationQoL

Outcome Measures

Primary Outcomes (4)

  • Jaw movement

    within 1 year after surgery

  • Jaw Functional Limitation Scale

    within 1 year after surgery

  • Bite force

    within 1 year after surgery

  • WHOQOL-BREF Taiwanese Version

    within 1 year after surgery

Study Arms (2)

Surgery

Craniotomy or Craniectomy

Control

age, gender and teeth condition matched

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects received craniotomy or craniectomy and age, gender and teeth condtion matched control subjects.

You may qualify if:

  • over 20 years old
  • post-craniotomy or post-craniectomy
  • able to follow order

You may not qualify if:

  • severe orofacial injury
  • severe teeth loss
  • significant changes of occlusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Study Officials

  • Jau-Yih Tsauo, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jau-Yih Tsauo, PhD

CONTACT

886-2-33668130jytsauo@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 22, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

TW(1)