UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018788 |
|---|---|
| Receipt number | 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 11:39:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
okuda@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021732
