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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
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