MR Images Variation With or Without Denture Wear | NCT03018158

Studies
MR Images Variation With or Without Denture Wear

NCT03018158

Sponsor

Nihon University

Status

Completed

Last Update Posted

Apr 11, 2018Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Magnetic Resonance Imaging

Interventions

denture wear.

Countries

Japan

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

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Dec 28, 2016

First Submission Date that Met QC Criteria

Jan 9, 2017

First Posted Date

Jan 11, 2017Estimated

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

Apr 9, 2018

Last Update Posted Date

Apr 11, 2018Actual

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

The objective of this study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.

Detailed Description

The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially to detect cancer and disk displacement with temporomandibular disorders. The prevalence of tongue cancer may increase with ageing population. A clear MR image is indispensable for clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be prominent with the patients without the occlusal support. The objective of this pilot study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dentulous	No Intervention	MR Imaging was collected with condition at the tongue at rest position.
edentulous without denture wear.	No Intervention	MR Imaging was collected without denture wear.
edentulous with denture wear.	Experimental	MR Imaging was collected with denture wear.	Device: denture wear.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
denture wear.	Device	MR Imaging was collected with or without denture wear.	edentulous with denture wear.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Luminance standard deviation value on MR image		MR Imaging was collected with each condition.Through study completion, an average of 2 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

dentulous
edentulous classified Eichner' s classfication

Exclusion Criteria:

involuntary motion occurs during imaging
absolutely contraindicated or as a rule contraindicated of MRI examination
subjects have ferromagnetic metals in the oral cavity
subjects can not swallow naturally

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasuhiko Kawai, DDS MSc PhD	Nihon University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nihon University Hospital		Matsudo	Chiba	2718587	Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019554	Dental Restoration Wear

Ancestor Terms

ID	Term
D003793	Dental Restoration, Permanent
D017266	Dental Prosthesis
D011476	Prosthodontics
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided