UMIN-CTR Clinical Trial

Basic information
Public title	Study for detection technology of caries,periodontitis and TMD using moving images
Acronym	Study for detection technology of caries,periodontitis and TMD using moving images
Scientific Title	Study for detection technology of caries,periodontitis and TMD using moving images
Scientific Title:Acronym	Study for detection technology of caries,periodontitis and TMD using moving images
Region	Japan

Condition
Condition	caries,periodontitis and TMD
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to obtain the chractaristic factors for diagnosis of caries,periodontitis and TMD from the photographic image and moving image.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	image change points
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Men and Women over 20 years of age at the time of obtaining informed consent (2)Patients in Tohoku University Hospital of dentistry 1)Caries Patiets who have C0 or C1 to C4 caries 2)Periodontitis Patients who have gingivitis, light periodontitis, moderate periodontitis or severe periodontitis 3)TMD Patients who have TMD symptom unilatraly
Key exclusion criteria	(1)Patients who has oral mucosal disease (2)Patinets with severe vomiting reflex (4)Patients who have judged that it is difficlt to participate in this study
Target sample size	210

Research contact person
Name of lead principal investigator	1st name Keiichi Middle name Last name Sasaki
Organization	Tohoku University Graduate School of Dentistry
Division name	Advanced Prosthetic Dentistry
Zip code	980-8575
Address	4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL	022-717-8368
Email	keii@dent.tohoku.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Hihara
Organization	Tohoku University Hospital
Division name	Advanced Prosthetic Dentistry
Zip code	9808575
Address	4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL	022-717-8369
Homepage URL
Email	hihara@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University Graduate School of Dentistry Research Ethics Committee
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
Tel	0227177056
Email	hihara@dent.tohoku.ac.jp

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	2018 Year 03 Month 12 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	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 28 Day
Date of IRB	2018 Year 02 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 05 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2018 Year 03 Month 12 Day
Last modified on	2019 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035895

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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