Influences of Types of Skull Surgery on Temporomandibular... | NCT01966939

Studies
Influences of Types of Skull Surgery on Temporomandibular Joint Performance

NCT01966939

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Oct 22, 2013Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Craniotomy
Craniectomy

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UN101-005	Other Grant/Funding Number	NTUH

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Oct 17, 2013

First Submission Date that Met QC Criteria

Oct 17, 2013

First Posted Date

Oct 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2013

Last Update Posted Date

Oct 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery		Craniotomy or Craniectomy
Control		age, gender and teeth condition matched

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jau-Yih Tsauo, PhD	Contact	886-2-33668130		jytsauo@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Jau-Yih Tsauo, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan