UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Application of Optical Coherence Tomography (OCT) for periodontal examination - noninvasive periodontal pocket depth measurement
Title of the study (Brief title)	Noninvasive periodontal pocket probing depth measurement using OCT
Region	Japan

Condition
Condition	Periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this research is to evaluate OCT as an apparatus for noninvasive periodontal pocket depth measurement using a contrast medium.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	OCT images with a contrast medium at anterior buccal side
Key secondary outcomes	pocket probing depth, intra oral photoes

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	Device,equipment
Interventions/Control_1	Taking OCT image of buccal side of anterior teeth with a contrast medium.
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Periodontally healthy adults.
Key exclusion criteria	Allergic to dairy products. Suffering from infectious disease.
Target sample size	30

Research contact person
Name of lead principal investigator	Akira Aoki
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-5803-5488
Email	aoperi@tmd.ac.jp

Public contact
Name of contact person	Akira Aoki
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-5803-5488
Homepage URL
Email	aoperi@tmd.ac.jp

Sponsor
Institute	Department of Periodontology, Graduate school of Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Grant for longevity science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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 04 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 04 Day
Anticipated trial start date	2016 Year 03 Month 04 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 04 Day
Last modified on	2018 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024605