CraniotomyNCT01966939
Influences of Types of Skull Surgery on Temporomandibular Joint Performance
An observational study of Craniotomy and Craniectomy, run by National Taiwan University Hospital at 1 site in Taiwan.
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) Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Craniotomy, Craniectomy
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects received craniotomy or craniectomy and age, gender and teeth condtion matched control subjects.
Who may be able to join
- over 20 years old
- post-craniotomy or post-craniectomy
- able to follow order
Who cannot join
- severe orofacial injury
- severe teeth loss
- significant changes of occlusion
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jau-Yih Tsauo, PhD, 886-2-33668130, jytsauo@ntu.edu.tw
About this study
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)
- Conditions
- Craniotomy, Craniectomy
- Keywords
- craniotomy, craniectomy, temporalis, TMJ, mastication, QoL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Craniotomy or Craniectomy | |
| Control | age, gender and teeth condition matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaw movement
Measured: within 1 year after surgery
Jaw Functional Limitation Scale
Measured: within 1 year after surgery
Bite force
Measured: within 1 year after surgery
WHOQOL-BREF Taiwanese Version
Measured: within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jau-Yih Tsauo, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966939
- Sponsor's protocol ID
- 201106049RC
- Other IDs
- UN101-005
- Status last verified
- Oct 2013
- First submitted
- 17 Oct 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Types of Skull Surgery on Temporomandibular Joint Performance
- ClinicalTrials.gov ID
- NCT01966939
- Acronym / sponsor ID
- 201106049RC
- Conditions
- Craniotomy, Craniectomy
- Keywords
- craniotomy, craniectomy, temporalis, TMJ, mastication, QoL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | –Craniotomy or Craniectomy |
| Control | – | –age, gender and teeth condition matched |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects received craniotomy or craniectomy and age, gender and teeth condtion matched control subjects.
Key inclusion criteria (3 listed)
- over 20 years old
- post-craniotomy or post-craniectomy
- able to follow order
Key exclusion criteria (3 listed)
- severe orofacial injury
- severe teeth loss
- significant changes of occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Jaw movement
Time frame: within 1 year after surgery
Jaw Functional Limitation Scale
Time frame: within 1 year after surgery
Bite force
Time frame: within 1 year after surgery
WHOQOL-BREF Taiwanese Version
Time frame: within 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jau-Yih Tsauo, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniotomy and Craniectomy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jau-Yih Tsauo, PhD (886-2-33668130, jytsauo@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw movement (time frame: within 1 year after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.