UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008645 |
|---|---|
| Receipt number | R000009970 |
| Scientific Title | Safety evaluation of a self-assembling peptide gel for the application as a hemostatic material in dentistry |
| Date of disclosure of the study information | 2012/08/28 |
| Last modified on | 2016/12/27 10:54:35 |
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Basic information
Public title
Safety evaluation of a self-assembling peptide gel for the application as a hemostatic material in dentistry
Acronym
Safety evaluation of a self-assembling peptide gel in dentistry
Scientific Title
Safety evaluation of a self-assembling peptide gel for the application as a hemostatic material in dentistry
Scientific Title:Acronym
Safety evaluation of a self-assembling peptide gel in dentistry
Region
| Japan |
Condition
Condition
Gingivitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety of non-animal derived self-assembling peptide gel, PanaceaGel for the application as a hemostatic material.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
Hemostatic effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Test product is put on marginl gingiva.
Interventions/Control_2
Placebo product is put on marginal gingiva.
Interventions/Control_3
Conventional product is put on marginal gingiva.
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
healthy dentist
Person who has 3 teeth with 4-6mm periodontal pockets and bleeding
Key exclusion criteria
excluding "key inclusion criteria"
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Takashiba |
Organization
Okayama University
Division name
Department of Pathophysiology-Periodontal Science, Graduate Schoolof Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6675
stakashi@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Takashiba |
Organization
Okayama University
Division name
Department of Pathophysiology-Periodontal Science, Graduate Schoolof Medicine, Dentistry and Pharmac
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6675
Homepage URL
stakashi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama Univesity
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 28 | 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
| 2012 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 08 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009970
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
