UMIN-CTR Clinical Trial

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