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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029237
Receipt No. R000033418
Scientific Title The effect of PRG barrier coat on prevention of dental caries to person with disability
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/21

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Basic information
Public title The effect of PRG barrier coat on prevention of dental caries to person with disability
Acronym The effect of coating material containing S-PRG filler on prevention of dental caries
Scientific Title The effect of PRG barrier coat on prevention of dental caries to person with disability
Scientific Title:Acronym 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
1st name
Middle name
Last name 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
Zip code
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
1st name
Middle name
Last name 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
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
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

Other
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

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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