UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044757 |
|---|---|
| Receipt number | R000050997 |
| Scientific Title | The study of adhesion effect of hypersensitivity inhibitors on the tooth surface |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/07/28 11:45:54 |
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Basic information
Public title
The study of adhesion effect of hypersensitivity inhibitors on the tooth surface
Acronym
The study of adhesion effect of hypersensitivity inhibitors
Scientific Title
The study of adhesion effect of hypersensitivity inhibitors on the tooth surface
Scientific Title:Acronym
The study of adhesion effect of hypersensitivity inhibitors
Region
| Japan |
Condition
Condition
hypersensitivity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adhesion efficiency of hypersensitivity inhibitors with novel monomers is investigated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A hypersensitivity inhibitor with coloring agent is applied to the tooth surface and photographed every week to determine the efficiency of adhesion.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Medicine |
Interventions/Control_1
BioCoat Ca (Medical Devices Agency: 230AKBZX00059000) with colorant is applied to the tooth surface only once.
Interventions/Control_2
Every week, intraoral photos are taken.
Photography is for a maximum of one year.
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
| 22 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The population is healthy adults in the university who applied by displaying posters.
Key exclusion criteria
Have an apparently malocclusion or caries.
Those determined by the physician in the case to be inappropriate for inclusion in this study.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fukumoto |
Organization
Tohoku Univ.
Kyushu Univ.
Division name
Pediatric Dent.
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
TEL
022-717-8382
fukumoto@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kan |
| Middle name | |
| Last name | Saito |
Organization
Tohoku Univ.
Division name
Pediatric Dent.
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
TEL
022-717-8382
Homepage URL
kanta@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Univ.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
Tel
022-717-8244
rinri-esct@proj.med.tohoku.ac.jp
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
| 2022 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/1996-1944/15/15/5172
Number of participants that the trial has enrolled
13
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 07 | Month | 26 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 07 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050997
