UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025022
Receipt number R000028793
Scientific Title Confirmatory Trial to Evaluate the Hydroxyapatite Layer Formed by Powder Jet Deposition for Treatment of Dentin Hypersensitivity
Date of disclosure of the study information 2016/12/02
Last modified on 2017/05/30 21:43:45

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Basic information

Public title

Confirmatory Trial to Evaluate the Hydroxyapatite Layer Formed by Powder Jet Deposition for Treatment of Dentin Hypersensitivity

Acronym

Confirmatory Trial to Evaluate the Hydroxyapatite Layer for Treatment of Dentin Hypersensitivity

Scientific Title

Confirmatory Trial to Evaluate the Hydroxyapatite Layer Formed by Powder Jet Deposition for Treatment of Dentin Hypersensitivity

Scientific Title:Acronym

Confirmatory Trial to Evaluate the Hydroxyapatite Layer for Treatment of Dentin Hypersensitivity

Region

Japan


Condition

Condition

Dentin Hypersensitivity

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We plan to conduct confirmatory trial for treatment of dentin hypersensitivity and obtain of pharmaceutical approval.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Air pain

Key secondary outcomes

Abrasion pain


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Formation of hydroxyapatite film

Interventions/Control_2

Treatment of teethmate-desensitizer

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Equal or more than 20 years old at the time of informed concent.
2. Agreement with written informed concent.
3. Capable of going to the hospital regularly
4. Drntal hypersensitivity:VAS>=30, split mouse design
5. Agreement with no treatment next to the test teeth

Key exclusion criteria

1. Patients who have oral mucosal diseases
2. Past medical history about adverse effects of local anesthetic
3. Pregnancy or possibility of pregnancy
4. Participants of other clinical trial
5. Taking painkillers
6. Patients who are judged as in adequate for this trial by the investigators

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keiichi Sasaki

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Advanced Prosthetic Dentistry

Zip code


Address

4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi

TEL

022-717-8369

Email

keii@dent.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kuniyuki Izumita

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Advanced Prosthetic Dentistry

Zip code


Address

4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi

TEL

022-717-8369

Homepage URL


Email

k-izumita@dent.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2016 Year 12 Month 02 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

Date of protocol fixation

2016 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 15 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

2016 Year 11 Month 28 Day

Last modified on

2017 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name