UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis of vertical root fractures by analyzing reconstructed three-dimensional models of bone defects obtained from Cone-Beam Computed Tomography images
Title of the study (Brief title)	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	Arata Ebihara
Organization	Endodontic Clinic of Tokyo Medical and Dental University
Division name	The Department of Pulp Biology and Endodontics
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	Arata Ebihara
Organization	Endodontic Clinic of Tokyo Medical and Dental University
Division name	The Department of Pulp Biology and Endodontics
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024597