UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013463 |
|---|---|
| Receipt number | R000015669 |
| Scientific Title | Evaluation of remineralization of root caries by application of nanoseal. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2018/01/26 20:37:20 |
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Basic information
Public title
Evaluation of remineralization of root caries by application of nanoseal.
Acronym
Root caries remineralization by nanoseal.
Scientific Title
Evaluation of remineralization of root caries by application of nanoseal.
Scientific Title:Acronym
Root caries remineralization by nanoseal.
Region
| Japan |
Condition
Condition
Root caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether Nanoseal stimulate remineralization of root caries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The degree of mineralization of root caries after 6 months of nanoseal use (the value of Daiagnodent).
Key secondary outcomes
Change of mineralization, size and color of root caries in a period of 6 months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Application of nanoseal to root caries. Experimental period; 6 months. Samples are devided into three groups; application every month or every 3 months for 6 months and control.
Interventions/Control_2
Root surface cleaning in all groups.
Interventions/Control_3
Use of tooth paste "Brosal" in all groups.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Root caries ranged to 40 from 1 of the diagnodent measurement. The patient performing the oral care at least once a day in the past 2 weeks.
Key exclusion criteria
Root caries applied with nanoseal previously.
Target sample size
129
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Miyaji |
Organization
Hokkaido University Hospital
Division name
Clinic of Endodontology and Periodontology
Zip code
Address
N14 W5, Kita-ku, Sapporo, 060-8648, Japan
TEL
011-706-4343
miyaji@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Miyaji |
Organization
Hokkaido University Hospital
Division name
Clinic of Endodontology and Periodontology
Zip code
Address
N14 W5, Kita-ku, Sapporo, 060-8648, Japan
TEL
011-706-4343
Homepage URL
miyaji@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Shika Yakuhin 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
| 2014 | Year | 04 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
| 2014 | Year | 03 | Month | 19 | Day |
Last modified on
| 2018 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015669
