UMIN-CTR Clinical Trial

Public title

A Non-Inferiority Study Evaluating Fibroblast Growth Factor-2 (KCB-1D) to Enamel Matrix Derivative (Emdogain(R)Gel) for Periodontal Tissue Regeneration.

Acronym

A Non-Inferiority Study Evaluating Fibroblast Growth Factor-2 (KCB-1D) to Enamel Matrix Derivative (Emdogain(R)Gel) for Periodontal Tissue Regeneration.

Scientific Title

A Non-Inferiority Study Evaluating Fibroblast Growth Factor-2 (KCB-1D) to Enamel Matrix Derivative (Emdogain(R)Gel) for Periodontal Tissue Regeneration.

Scientific Title:Acronym

A Non-Inferiority Study Evaluating Fibroblast Growth Factor-2 (KCB-1D) to Enamel Matrix Derivative (Emdogain(R)Gel) for Periodontal Tissue Regeneration.

Region

Japan

Condition

patients with periodontitis who require surgical intervention (flap surgery)

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to compare the effectiveness of fibroblast growth factor-2 (KCB-1D) with enamel matrix derivative (Emdogain(R)Gel) in patients with periodontitis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

linear alveolar bone growth at 36 weeks after administration

Key secondary outcomes

change of clinical attachment level, probing pocket depth and gingival recession at 36 weeks after administration

adverse events and adverse drug reactions

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Device,equipment

Interventions/Control_1

KCB-1D group
Adequate volume of KCB-1D will be administered to the lesion during flap surgery.

Interventions/Control_2

EMD group
Adequate volume of Emdogain(R)Gel will be administered to the lesion during flap surgery.

Interventions/Control_3

FOP group
Flap surgery only

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1.diagnosed as periodontitis requiring flap surgery after successful initial preparation
2.with vertical intrabony defect 4 mm or deeper on radiographs
3.with probing pocket depth 6 mm or deeper, with mobility of tooth 2 degree or less, and with width of keratinized gingiva for which flap surgery is considered appropriate

Key exclusion criteria

1. coexisting with a malignant tumor or history thereof
2. having taken bisphosphonates or coexisting with osteoporosis
3.coexisting with gingival overgrowth or history of the same
4.suspected of a oral malignant/premalignant tumor
5. determined inappropriate for using Emdogain(R)Gel or participating in this study by investigators
6.coexisting with other dental diseases with potential to cause some effects on periodontal healing at the test site (apical periodontitis or root fractures, etc)
7. scheduled to receive surgical, prosthodontic or endodontic treatments at the test site within 36 weeks
8. with dental prosthesis interrupting accurate evaluation of clinical attachment level
9.with bony defects in need of bone grafts, or suspected of severe gingival recession after flap surgery

Target sample size

240

Name of lead principal investigator

1st name
Middle name
Last name	Akira Takahashi

Organization

Kaken Pharmaceutical Co., LTD.

Division name

Clinical Development Department

Zip code

Address

28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan

TEL

03-5977-5111

Email

takahashi_akira@kaken.co.jp

Name of contact person

1st name
Middle name
Last name	Motoki Akamatsu

Organization

KAKEN PHARMACEUTICAL CO., LTD.

Division name

Clinical Development Department

Zip code

Address

28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan

TEL

03-5977-5111

Homepage URL

Email

akamatsu_motoki@kaken.co.jp

Institute

KAKEN PHARMACEUTICAL CO., LTD.

Institute

Department

Personal name

Organization

KAKEN PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN

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

2012

Year

06

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

2012

Year

06

Month

08

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

06

Month

22

Day

Last modified on

2014

Year

11

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009702