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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013463
Receipt No. 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

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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
Email 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
Email miyaji@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
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

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015669

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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