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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018788
Receipt No. R000021732
Scientific Title Tissue-engineered cultured periosteum used with platelet-rich plasma and hydroxyapatite in treating human osseous defects: second phase of clinical trial.
Date of disclosure of the study information 2015/08/24
Last modified on 2017/08/25

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Basic information
Public title Tissue-engineered cultured periosteum used with platelet-rich plasma and hydroxyapatite in treating human osseous defects: second phase of clinical trial.
Acronym Clinical effect of cultured periosteal sheet for treating chronic periodontitis.
Scientific Title Tissue-engineered cultured periosteum used with platelet-rich plasma and hydroxyapatite in treating human osseous defects: second phase of clinical trial.
Scientific Title:Acronym Clinical effect of cultured periosteal sheet for treating chronic periodontitis.
Region
Japan

Condition
Condition Chronic periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of a new therapy to treat periodontal defect using tissue-engineered periosteum, platelet-rich plasma and artificial bone material.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Clinical Attachment Levelat 12-month postsurgery.
Key secondary outcomes Radiographic Infrabony Defect Depth at 12-month postsurgery.

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 Single arm
1. 30 patients
2. At periodontal surgery after
debridement, the coagulated platelet-rich
plasma and hydroxyapatite granules was
placed into the defect and then cultured
periosteal sheet was overlaid onto them
as interventions.


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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. 20 years or older and 80 years younger persons who obtained written informed consent.
2. Persons satisfied with a standard of biosafety level 1.
3. Free of systemic complications.
4. Completion of periodontal initial treatment.
5. Accept for periodontal surgery.
6. Persons who had one infrabony defect with probing depth: 6mm and more, clinical attachment level:6mm and more. Osseous defect depth estimated to be 4mm and more radiographically.
Key exclusion criteria 1. Persons who do not accept written informed consent.
2. Persons not satisfied with a standard of biosafety level 1.
3. Persons who had severe systemic complications.
4. Un-completion of periodontal initial treatment.
5. Persons who were unable to accept for periodontal surgery.
6. Persons who had not one infrabony defect with probing depth: 6mm and more, clinical attachment level: 6mm and more. and osseous defect depth estimated to be 4mm and more radiographically.
7. Persons who had the allergy due to medication.
8. Persons who are judged to be unqualified for this study subjects by investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Okuda
Organization Niigata University
Division name Graduate School of Medical and Dental Sciences
Zip code
Address 2-5274 Gakkocho-dori, Chuo-ku, Niigata, 951-8514 Japan
TEL 0252272870
Email okuda@dent.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Okuda
Organization Niigata University
Division name Graduate School of Medical and Dental Sciences
Zip code
Address 2-5274 Gakkocho-dori, Chuo-ku, Niigata, 951-8514 Japan
TEL 0252272870
Homepage URL
Email okuda@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization 1)Niigata University Clinical Research Fund
2)Grant-in-Aid for Scientific Research
from the Ministry of Education, Sports,
Science, and Technology, Japan.
Organization
Division
Category of Funding Organization Other
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
2015 Year 08 Month 24 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
2006 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 24 Day
Last modified on
2017 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021732

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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