UMIN-CTR Clinical Trial

Public title

Study for Autologous Blood-Derived Fibrin Gel (CGF) in Root-end Resection

Acronym

Utilization of Autologous Blood-Derived Fibrin Gel in Root-end Resection

Scientific Title

Study for Autologous Blood-Derived Fibrin Gel (CGF) in Root-end Resection

Scientific Title:Acronym

Utilization of Autologous Blood-Derived Fibrin Gel in Root-end Resection

Region

Japan

Condition

Apical periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify positively recovery of alveolar bone lost due to apical periodontitis, we verify the effect of root-end resection combined with CGF which is high bone regeneration inducing ability.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Dental cone-beam CT imaging at 6 months post operation

Key secondary outcomes

Measurement of lesion reduction ratio (dental X-ray photography every 3 months until 12 months post operation).Immediately after surgery, the presence or absence of pain, chest pain and apical tenderness during the follow-up period is judged

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CGF injection group

Interventions/Control_2

non-injection group

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

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patients who are considered to be effective means of root-end resection for solving the main complaint of the patient and expectation of hope
2. Patients with good overall condition
3. Patients with platelet counts of 100,000 / mm 3 or more
4. Patients aged 20 to 70
5. The consent of research participation is obtained by the document

Key exclusion criteria

1. Patients with malignant tumor complicated or having a history
2. Patients with abnormal gingival proliferation or having a history of abnormal gingival proliferation
3. Malignant tumor, premalignant lesion or finding that they are suspected by intraoral diagnosis
4. Patients under 20 or over 70
5. Other patients who are suffering from severe infectious diseases etc. Patients who are judged to be inappropriate for dental practitioners providing this regenerative medicine, etc. from the viewpoint of safety measures etc. to the person who manufactures the following items Consider taking the interview and examination.
(A) Hepatitis B virus (HBV)
(B) Hepatitis C virus (HCV)
(C) Human immunodeficiency virus (HIV)
(D) Human T cell leukemia virus type 1 (HTLV-1)

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Masahiro Saito

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Operative Dentistry

Zip code

Address

4-1,Seiryo-machi, Aoba-ku,Sendai,Miyagi, Japan

TEL

022-717-8340

Email

mssaito@dent.tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Masahiro Saito

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Operative Dentistry

Zip code

Address

4-1,Seiryo-machi, Aoba-ku,Sendai,Miyagi, Japan

TEL

022-717-8340

Homepage URL

Email

mssaito@dent.tohoku.ac.jp

Institute

Japanese Association for Dental Science

Institute

Department

Personal name

Organization

Japanese Association for Dental Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

PC2180014

Org. issuing International ID_1

Tohoku Regional Bureau of Health and Welfare

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学病院（宮城県）、東京医科歯科大学歯学部付属病院（東京都）、大阪大学歯学部付属病院（大阪府）、新潟大学医歯総合病院（新潟県）

Date of disclosure of the study information

2019

Year

02

Month

15

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

Enrolling by invitation

Date of protocol fixation

2019

Year

02

Month

14

Day

Date of IRB

Anticipated trial start date

2019

Year

02

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

02

Month

14

Day

Last modified on

2019

Year

02

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040880