UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035878 |
|---|---|
| Receipt number | 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 17:29:35 |
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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
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
mssaito@dent.tohoku.ac.jp
Sponsor or person
Institute
Japanese Association for Dental Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040880
