UMIN-CTR Clinical Trial

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

Chronic periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Clinical Attachment Levelat 12-month postsurgery.

Key secondary outcomes

Radiographic Infrabony Defect Depth at 12-month postsurgery.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Niigata University

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

08

Month

24

Day

URL releasing protocol

Publication of results

Published

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

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 related 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