UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bone regeneration for alveolar bone regeneration using platelet rich plasma
Title of the study (Brief title)	Bone regeneration for alveolar bone regeneration using platelet rich plasma
Region	Japan

Condition
Condition	bone defect
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clinically evaluate the efficacy of platelet rich plasma induced from autogenous blood for alveolar bone regeneration in the treatment of dental implant.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	At 3, 7 and 30 days after surgery, we evaluate the surgical site in accordance with 1: good, 2: normal, 3: delay.
Key secondary outcomes	1. The surgical site At 3, 7 and 30 days after surgery, we evaluate the surgical site as followed subjects. 1: good, 2: normal, 3: delay. 2. The postoperative infection 1: good, 2: normal, 3: bad. 3. The postoperative bone formation (with radiographic examination) The height and width measurment 4. The initial osseointegration 1: good, 2: normal, 3: poor.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The autogenous venous blood collected from the patient to be centrifuged to concentrate the platelet rich plasma (=PRP). PRP with the autogenous bone is grafted for the surgical site.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient for alveolar bone augmentation.
Key exclusion criteria	none
Target sample size	30

Research contact person
Name of lead principal investigator	Takaaki Ueno
Organization	OsakaMedoical College
Division name	Dept. of Oral Surgery and Dentistry
Address	2-7 Daigakumachi, Takatsuki-city, Osaka
TEL	072-683-1221
Email	ueno@poh.osaka-u.ac.jp

Public contact
Name of contact person	Yuichi Itto
Organization	OsakaMedoical College
Division name	Dept. of Oral Surgery and Dentistry
Address	2-7 Daigakumachi, Takatsuki-city, Osaka
TEL	072-683-1221
Homepage URL
Email	ora059@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	大阪医科大学付属病院

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 05 Day
Anticipated trial start date	2012 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 16 Day
Last modified on	2016 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014731