UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for application of optical coherence tomography (OCT) in sinus augmentation procedures
Title of the study (Brief title)	Application of OCT for crestal sinus augmentation.
Region	Japan

Condition
Condition	missing teeth of upper jaw
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm whether maxillary sinus floor could be detected by OCT during performing sinus augmentation procedure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Alteration of converted electrical signal from OCT
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	Device,equipment
Interventions/Control_1	Capturing the OCT image during surgical operation
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	Patients receive sinus augmentation procedure (crestal approach)
Key exclusion criteria	Nothing
Target sample size	10

Research contact person
Name of lead principal investigator	Makoto Shiota
Organization	Tokyo Medical and Dental University
Division name	Oral Implantology and Regenerative Dental Medicine
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-5803-5774
Email	mshiota.impl@tmd.ac.jp

Public contact
Name of contact person	Makoto Shiota
Organization	Tokyo Medical and Dental University
Division name	Oral Implantology and Regenerative Dental Medicine
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-5803-5774
Homepage URL
Email	mshiota.impl@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	MHLW GRANTS
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	2016 Year 07 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 15 Day
Anticipated trial start date	2016 Year 06 Month 20 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	2016 Year 07 Month 21 Day
Last modified on	2018 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026813