MR Images Variation With or Without Denture Wear

MR Images Variation With or Without Denture Wear. Motion Artifacts Related With Tongue Movements

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

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Device: denture wear.

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Matsudo, Chiba, Japan, 2718587
      • Nihon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: dentulous; MR Imaging was collected with condition at the tongue at rest position.
No Intervention: edentulous without denture wear.; MR Imaging was collected without denture wear.
Experimental: edentulous with denture wear.; MR Imaging was collected with denture wear.	Device: denture wear.; MR Imaging was collected with or without denture wear.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nihon University
• Investigators: Study Chair: Yasuhiko Kawai, DDS MSc PhD, Nihon University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: EC 15-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO