UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Invention and application for clinical diagnosis of dental OCT (optical coherence tomography)
Title of the study (Brief title)	Invention and application for clinical diagnosis of dental OCT (optical coherence tomography)
Region	Japan

Condition
Condition	caries restorative material endodontitis periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Invent and innovate dental OCT to clinical dentistry.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	degree of caries progression gap, fracture state pulp chamber shape of periodontal tissue
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Introduction of new diagnosis device in dental treatment.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Any patient who provides consent.
Key exclusion criteria	Patients who don't provide consent.
Target sample size	300

Research contact person
Name of lead principal investigator	Junji Tagami
Organization	Tokyo Medial and Dental University
Division name	Cariology and Operative Dentistry
Address	Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL	03-5803-5483
Email	tagami.ope@tmd.ac.jp

Public contact
Name of contact person	Junji Tagami
Organization	Tokyo Medial and Dental University
Division name	Cariology and Operative Dentistry
Address	Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL	03-5803-5483
Homepage URL
Email	tagami.ope@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2019 Year 03 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2010 Year 11 Month 08 Day
Anticipated trial start date	2010 Year 11 Month 08 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

Management information
Registered date	2018 Year 05 Month 30 Day
Last modified on	2018 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037410