UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038681 |
|---|---|
| Receipt number | R000044025 |
| Scientific Title | Platelet-rich fibrin for keratinized immobile mucosa dilation |
| Date of disclosure of the study information | 2019/11/30 |
| Last modified on | 2019/11/25 15:31:02 |
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Basic information
Public title
Platelet-rich fibrin for keratinized immobile mucosa dilation
Acronym
Platelet-rich fibrin for keratinized immobile mucosa dilation
Scientific Title
Platelet-rich fibrin for keratinized immobile mucosa dilation
Scientific Title:Acronym
Platelet-rich fibrin for keratinized immobile mucosa dilation
Region
| Japan |
Condition
Condition
Insufficient keratinization of gingiva around implants
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The keratinized gingival widens around the implant
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To evaluate the width of keratinized gingiva around the implant after widening
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
implant patients greater than 18, dental implanting operation at least four months, and < 2 mm of KIM on implant sites in the lower jaw. Smokers, patients with systemic diseases, patients allergic to adrenaline and iodine, and patients with implantation operation less than four months before the study were excluded from the study.
Key exclusion criteria
implant patients less than 18, dental implanting operation at least four months, and
more than 2 mm of KIM on implant sites in the lower jaw. Smokers, patients with systemic diseases, patients allergic to adrenaline and iodine, and patients with implantation operation less than four months before
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | shouhe |
| Middle name | |
| Last name | kasugai |
Organization
tokyo medical and dental university
Division name
Oral Implantology and Regenerative Dental Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL
0358034092
kas.mfc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | fangshuo |
| Middle name | |
| Last name | wang |
Organization
tokyo medical and dental university
Division name
Oral Implantology and Regenerative Dental Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL
0358034092
Homepage URL
kas.mfc@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university Oral Implantology and Regenerative Dental Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and dental university Oral Implantology and Regenerative Dental Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo medical and dental university Oral Implantology and Regenerative Dental Medicine
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
Tel
0358034092
kas.mfc@tmd.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
| 2019 | Year | 11 | Month | 30 | 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
3
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044025
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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