UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029237 |
|---|---|
| Receipt number | 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 21:39:26 |
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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
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
yawaka@den.hokudai.ac.jp
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033418
