UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019682 |
|---|---|
| Receipt number | R000022704 |
| Scientific Title | Study of clinical evaluation of PRG barrier coat |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2018/11/20 13:39:09 |
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Basic information
Public title
Study of clinical evaluation of PRG barrier coat
Acronym
PRG barrier coat study
Scientific Title
Study of clinical evaluation of PRG barrier coat
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Sato Hideo |
Organization
Kagoshima University
Division name
Hospital
Zip code
Address
Sakuragaoka8-35-1, Kagoshima city
TEL
099-275-6262
hideo-sato@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sato Hideo |
Organization
Kagoshima University
Division name
Hospital
Zip code
Address
Sakuragaoka8-35-1, Kagoshima city
TEL
099-275-6262
Homepage URL
hideo-sato@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Department of Pediatric Dentistry
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 29 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022704
