UMIN-CTR Clinical Trial

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

Vertical Root Fracture

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

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

Organization

Endodontic Clinic of Tokyo Medical and Dental
University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

03

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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