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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025022
Receipt No. 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

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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
Institute Tohoku University Graduate School of Dentistry
Institute
Department

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
URL(English) https://upload.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


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