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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035878
Receipt No. R000040880
Scientific Title Study for Autologous Blood-Derived Fibrin Gel (CGF) in Root-end Resection
Date of disclosure of the study information 2019/02/15
Last modified on 2019/02/15

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Basic information
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
Condition Apical periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Japanese Association for Dental Science
Institute
Department

Funding Source
Organization Japanese Association for Dental Science
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
Email

Secondary IDs
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
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)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 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
Other related information

Management information
Registered date
2019 Year 02 Month 14 Day
Last modified on
2019 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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