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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006594
Receipt No. R000007802
Scientific Title Investigation of efficacy and safety for periodontal regeneration using controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel
Date of disclosure of the study information 2011/10/23
Last modified on 2016/05/11

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Basic information
Public title Investigation of efficacy and safety for periodontal regeneration using controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel
Acronym Periodontal regeneration with controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel
Scientific Title Investigation of efficacy and safety for periodontal regeneration using controlled release of platelet-rich plasma impregnated in biodegradable gelatin hydrogel
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Kazuhiro Gomi
Organization Tsurumi University School of Dental Medicine
Division name Department of Periodontology
Zip code
Address 2-1-3 Tsurumi, Tsurumi-ku Yokohama JAPAN
TEL 0455811001
Email gomi-k@tsurumi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikimoto Kanazashi
Organization Tsurumi University School of Dental Medicine
Division name Department of Periodontology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 04 Month 29 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007802

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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