UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of clinical evaluation of PRG barrier coat
Title of the study (Brief title)	PRG barrier coat study
Region	Japan

Condition
Condition	healthy teeth, dental caries, enamel hypomineralization
Classification by specialty	Dental medicine Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical efficacy evaluation of PRG barrier coat
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of degree of dental caries after applied, one month later, three month later, six month later, one year later, two year later
Key secondary outcomes	age, sex, medical history, applied position, applied condition

Base
Study type	Interventional

Study design
Basic design	expanded access
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	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	applied of PRG barrier coat every one month till two years
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	1 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	dental caries carrier or high dental caries lisk
Key exclusion criteria	no
Target sample size	100

Research contact person
Name of lead principal investigator	Sato Hideo
Organization	Kagoshima University
Division name	Hospital
Address	Sakuragaoka8-35-1, Kagoshima city
TEL	099-275-6262
Email	hideo-sato@dent.kagoshima-u.ac.jp

Public contact
Name of contact person	Sato Hideo
Organization	Kagoshima University
Division name	Hospital
Address	Sakuragaoka8-35-1, Kagoshima city
TEL	099-275-6262
Homepage URL
Email	hideo-sato@dent.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Department of Pediatric Dentistry
Institute
Department

Funding Source
Organization	Shofu Co. Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 29 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date	2018 Year 03 Month 30 Day
Date of closure to data entry	2018 Year 03 Month 30 Day
Date trial data considered complete	2018 Year 03 Month 30 Day
Date analysis concluded	2018 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 08 Day
Last modified on	2018 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022704