NCT03018158

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

December 28, 2016

Last Update Submit

April 9, 2018

Conditions

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Luminance standard deviation value on MR image

    MR Imaging was collected with each condition.Through study completion, an average of 2 year

Study Arms (3)

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

denture wear.DEVICE

MR Imaging was collected with or without denture wear.

edentulous with denture wear.

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dentulous
  • edentulous classified Eichner' s classfication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nihon University Hospital

Matsudo, Chiba, 2718587, Japan

Location

MeSH Terms

Interventions

Dental Restoration Wear

Intervention Hierarchy (Ancestors)

Dental Restoration, PermanentDental ProsthesisProsthodonticsDentistry

Study Officials

  • Yasuhiko Kawai, DDS MSc PhD

    Nihon University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.Yasuhiko kawai

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 11, 2017

Study Start

December 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)