UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tissue-engineered cultured periosteum used with platelet-rich plasma and hydroxyapatite in treating human osseous defects: second phase of clinical trial.
Title of the study (Brief title)	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	Kazuhiro Okuda
Organization	Niigata University
Division name	Graduate School of Medical and Dental Sciences
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	Kazuhiro Okuda
Organization	Niigata University
Division name	Graduate School of Medical and Dental Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 05 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021732