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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036234
Receipt No. R000040996
Scientific Title Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Date of disclosure of the study information 2019/03/17
Last modified on 2019/03/19

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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
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
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

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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