UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of PRG barrier coat on prevention of dental caries to person with disability
Title of the study (Brief title)	The effect of coating material containing S-PRG filler on prevention of dental caries
Region	Japan Asia(except Japan)

Condition
Condition	incipient caries
Classification by specialty	Dental medicine Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The consideration of the effect of coating material containing S-PRG filler on incipient caries with high-risk enviroment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the amount of change DIAGNOdent data before and after application the coating
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Only one coating usa One year observation
Interventions/Control_2	No coating One year observation
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	6 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1:The person who get Informed consent forms from doner or proxies 2:The person who have permanent tooth with incipient caries(ICDA:coad1 or coad2) and healthy tooth(ICDAS:coad0) 3:The person who have over 20% Plaque Control Record(PCR)
Key exclusion criteria	1:The person who can't visit clinic regularly 2:The person who can't take medial examination with cooperative relationship 3:The person who we think unfit for this study
Target sample size	38

Research contact person
Name of lead principal investigator	Yasutaka Yawaka
Organization	Department of Oral Functional Science, Division of Dental Medicine, Faculty of Dental Medicine and Graduate School of Dental Medicine
Division name	Dentistry for Children and Disabled Persons
Address	Nishi7,North13-jyo,Kita-ku,Sapporo-shi,Hokkaido,JAPAN
TEL	011-706-4292
Email	yawaka@den.hokudai.ac.jp

Public contact
Name of contact person	Yasutaka Yawaka
Organization	Department of Oral Functional Science, Division of Dental Medicine, Faculty of Dental Medicine and G
Division name	Dentistry for Children and Disabled Persons
Address	Nishi7,North13-jyo,Kita-ku,Sapporo-shi,Hokkaido,JAPAN
TEL	011-706-4292
Homepage URL
Email	yawaka@den.hokudai.ac.jp

Sponsor
Institute	Dentistry for Children and Disabled Persons,Department of Oral Functional Science, Division of Dental Medicine, Faculty of Dental Medicine and Graduate School of Dental Medicine
Institute
Department

Funding Source
Organization	SHOFU INC.
Organization
Division
Category of Funding Organization	Other
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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 10 Month 01 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	2017 Year 09 Month 21 Day
Last modified on	2017 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033418