UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of efficacy and safety for periodontal regeneration using controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel
Title of the study (Brief title)	Periodontal regeneration with controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel
Region	Japan

Condition
Condition	Periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the efficacy and safety of periodontal regeneration using controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome of this study is to evaluate the efficacy for periodontal regeneration using controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydroge
Key secondary outcomes	The secondary outcome of this study is to evaluate the clinical safety for periodontal regeneration using controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel

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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel is transplanted to periodontal bone defect during the flap procedure
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	1) Patients having intrabony periodontal defects with probing pocket depth more than 4 mm after initial preparation. Radiographic evidence of intrabony defects had to exist 2) Patients who can give informed consent themselves in writing
Key exclusion criteria	1) Patients with any systemic illness known to affect the outcomes of periodontal regeneration 2) Pregnancy and/or lactation 3) The habit of smoking or use of other tobacco prodacts 4) Other(doctors dicision)
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuhiro Gomi
Organization	Tsurumi University School of Dental Medicine
Division name	Department of Periodontology
Address	2-1-3 Tsurumi, Tsurumi-ku Yokohama JAPAN
TEL	0455811001
Email	gomi-k@tsurumi-u.ac.jp

Public contact
Name of contact person	Mikimoto Kanazashi
Organization	Tsurumi University School of Dental Medicine
Division name	Department of Periodontology
Address	2-1-3 Tsurumi, Tsurumi-ku Yokohama JAPAN
TEL	045-581-1001
Homepage URL
Email	kanazashi-m@tsurumi-u.ac.jp

Sponsor
Institute	Department of Periodontology, Tsurumi University School of Dental Medicine
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	Japan research foundation for clinical pharmacology
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 29 Day
Anticipated trial start date	2012 Year 07 Month 11 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2011 Year 10 Month 23 Day
Last modified on	2016 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007802