UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006594 |
|---|---|
| Receipt number | 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 20:31:33 |
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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
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
kanazashi-m@tsurumi-u.ac.jp
Sponsor or person
Institute
Department of Periodontology, Tsurumi University School of Dental Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007802
