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
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
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
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
