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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038681
Receipt No. 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

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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
Email 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
Email kas.mfc@tmd.ac.jp

Sponsor
Institute Tokyo medical and dental university Oral Implantology and Regenerative Dental Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044025

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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