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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021432
Receipt No. 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

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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
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

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
URL(English) https://upload.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


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