UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Acronym	Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Scientific Title	Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Scientific Title:Acronym	Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Region	Japan

Condition
Condition	Atrophic maxillary alveolar bone
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety of Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Scientific validity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Platelet rich plasma transplantation
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A patient MUST: 1) Have missing tooth in the maxillary posterior region. 2) Require dental implant treatment at missing tooth site. 3) Require sinus floor augmentation (socket lift) at the dental implant placement. 4) Have good systemic condition. 5) Number of platelet is over 1x10E5 /microliter. 6) 20 years and older. 7) Other,the investigator believes makes him/her suitable for participation in this clinical study.
Key exclusion criteria	Patient MUST NOT: 1) Have a history of Complicate malignant tumor. 2) Have an abnormal gingival proliferation or having a history of abnormal gingival proliferation. 3) Suspected of oral malignant tumor or precancerous lesion. 4) Under 20 years of old. 5) Have anti-coagulant or anti-platelet medications, or have a bleeding disorders. 6) Pregnancy, breastfeeding, or possibility of pregnancy. 7) Other,the investigator believes makes him/her unsuitable for participation in the clinical study.
Target sample size	2

Research contact person
Last name of lead principal investigator	1st name Morikuni Middle name Last name Tobita
Organization	Juntendo Hospital, Juntendo university school of medicine
Division name	Department of Oral and Maxillofacial Surgery
Zip code	113-8431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Email	mtobita@juntendo.ac.jp

Public contact
1st name of contact person	1st name Morikuni Middle name Last name Tobita
Organization	Juntendo Hospital, Juntendo university school of medicine
Division name	Department of Oral and Maxillofacial Surgery
Zip code	113-8431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Homepage URL
Email	mtobita@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	None
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	Ethical Review Board of Juntendo University Faculty of Medicine
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-3813-3111
Email	rinri@juntendo.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	順天堂大学附属順天堂医院（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 17 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	Open public recruiting
Date of protocol fixation	2019 Year 03 Month 14 Day
Date of IRB	2019 Year 03 Month 18 Day
Anticipated trial start date	2019 Year 03 Month 18 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 17 Day
Last modified on	2019 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040996