UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021432
Receipt number R000024597
Scientific Title Diagnosis of vertical root fractures by analyzing reconstructed three-dimensional models of bone defects obtained from Cone-Beam Computed Tomography images
Date of disclosure of the study information 2016/03/11
Last modified on 2018/03/19 16:50:09

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Basic information

Public title

Diagnosis of vertical root fractures by analyzing reconstructed three-dimensional models of bone defects obtained from Cone-Beam Computed Tomography images

Acronym

Diagnosis of VRF by analyzing reconstructed 3D models from CBCT images

Scientific Title

Diagnosis of vertical root fractures by analyzing reconstructed three-dimensional models of bone defects obtained from Cone-Beam Computed Tomography images

Scientific Title:Acronym

Diagnosis of VRF by analyzing reconstructed 3D models from CBCT images

Region

Japan


Condition

Condition

Vertical Root Fracture

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the new diagnostic method of vertical root fractures by analyzing reconstructed three-dimensional models of bone defects obtained from CBCT images

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The volume of reconstructed three-dimensional models of bone defects obtained from CBCT images were calculated and analyzed. We will predict the vertical root fracture diagnosis. We will analyze and compare the prediction and the established diagnosis.

Key secondary outcomes

The morphological evaluation of reconstructed three-dimensional models of bone defects obtained from CBCT images


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who visited the Endodontic Clinic of Tokyo Medical and Dental University Hospital and had the tooth suspected as vertical root fracture by the clinical signs, symptoms and radiographic appearances were chosen.

Key exclusion criteria

Patients did not agree on this research.

Patients cannot be taken CBCT scans.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Arata Ebihara

Organization

Endodontic Clinic of Tokyo Medical and Dental
University

Division name

The Department of Pulp Biology and Endodontics

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN

TEL

03-5803-5494

Email

a.ebihara.endo@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Arata Ebihara

Organization

Endodontic Clinic of Tokyo Medical and Dental University

Division name

The Department of Pulp Biology and Endodontics

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN

TEL

03-5803-5494

Homepage URL


Email

a.ebihara.endo@tmd.ac.jp


Sponsor or person

Institute

Department of Pulp Biology and Endodontics, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU)

Institute

Department

Personal name



Funding Source

Organization

Endodontic Clinic of Tokyo Medical and Dental
University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 11 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2016 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This work will be performed in the 2016-2019 period.

We will explain this research, asking some cooperation with this research of the members in our department.

We will protect of personal information.

Observers evaluate consecutive CBCT images in each section (mesiodistal, buccolingual
and horizontal), meaning that CBCT images
have only been evaluated using two-dimensional (2D)images. In this study, three-dimensional models(TDMs) were reconstructed from the mesiodistal, buccolingual and horizontal sections of CBCT images.

We evaluate the accuracy of vertical root fracture diagnosis based on the shape and volume of bone defects in TDMs.

We compare the prediction and established diagnosis of vertical root fracture.

The diagnosis of a vertical root fracture is confirmed by the observation of a fracture line.

There are three ways to confirm the fracture line.The dentist will choose the best way.

a.Observation in the root canal under an microscope during the root canal treatment.
b. A fracture line was confirmed under an operating microscope during a surgical procedure.
c. A fracture line was confirmed after the extraction.




Management information

Registered date

2016 Year 03 Month 11 Day

Last modified on

2018 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024597


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name