MR Images Variation With or Without Denture Wear

NCT ID: NCT03018158

Last Updated: 2018-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Magnetic Resonance Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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dentulous

MR Imaging was collected with condition at the tongue at rest position.

Group Type NO_INTERVENTION

No interventions assigned to this group

edentulous without denture wear.

MR Imaging was collected without denture wear.

Group Type NO_INTERVENTION

No interventions assigned to this group

edentulous with denture wear.

MR Imaging was collected with denture wear.

Group Type EXPERIMENTAL

denture wear.

Intervention Type DEVICE

MR Imaging was collected with or without denture wear.

Interventions

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denture wear.

MR Imaging was collected with or without denture wear.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nihon University

OTHER

Sponsor Role lead

Responsible Party

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Yasuhiko Kawai

Professor Dr.Yasuhiko kawai

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasuhiko Kawai, DDS MSc PhD

Role: STUDY_CHAIR

Nihon University

Locations

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Nihon University Hospital

Matsudo, Chiba, Japan

Site Status

Countries

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Japan

Other Identifiers

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EC 15-019

Identifier Type: -

Identifier Source: org_study_id

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