UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009441 |
|---|---|
| Receipt number | R000008691 |
| Scientific Title | Pulp regeneration after pulpectomy by transplantation of autologous pulp stem cells. |
| Date of disclosure of the study information | 2012/12/03 |
| Last modified on | 2019/06/07 10:39:33 |
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Basic information
Public title
Pulp regeneration after pulpectomy by transplantation of autologous pulp stem cells.
Acronym
Pulp regeneration with dental pulp stem cells.
Scientific Title
Pulp regeneration after pulpectomy by transplantation of autologous pulp stem cells.
Scientific Title:Acronym
Pulp regeneration with dental pulp stem cells.
Region
| Japan |
Condition
Condition
irreversible pulpitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In place of artificial filling, autologous pulp stem cells are transplanted in pulpectomized teeth together with G-CSF of the GMP product to establish safety, feasibility and efficacy of pulp regeneration in the pulpitis model.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
systemic finding
oral manifestation
extraction socket finding
blood test
blood chemistry examination
Urine chemistry examination
periapical swelling
tenderness, percussion pain
Key secondary outcomes
electric pulp test
radio lucency at the apex
psychroalgia, pain to hot and cold, spontaneous pain, tenderness, percussion pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
transplantation of pulp stem cells with G-CSF
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients to whom the research plan has been explained orally and by a document, and from whom the consent of his or her participation has been obtained directly by a doccument without any compulsion
2) Outpatients
3) Patients who have irreversible pulpitis in the single root canal
4) Patients who have unnesessary and/or discarded teeth (including wisdom tooth, the surplus dislocated tooth, expendientry extracted tooth for orthodontic treatment without occlusion) which can supply pulp tissue
5) Patients who have enough residual healthy tooth structure over alveolar bone, confirming by a X ray micrograph, completely preventing microleakage in the root canal by resin partitions
6) Patients who have no tooth fracture detected by a X ray micrograph
7) Patients who have no periapical radiolucency
Key exclusion criteria
1) patients who have a difficulty in collecting peripheral blood
2) patients who has infection, such as virus, bacteria, fungus or mycoplasma
3) cardiovascular disease patients
4) patients taking anticoagulants or antiplatelet agents
5) diabetes (more than HbA1c 6.1%)
6) osteoporosis
7) pregnant woman, expectant pregnant woman
8) patients who have a past history of allergy with any antimicrobial agent or local anesthetia
9) patients who have a difficulty in getting the consent, such as mentally retarded or mentally illness persons
10) persons to whom the principal investigator of the clinical trial in charge consider to be inappropriate
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Misako |
| Middle name | |
| Last name | Nakashima |
Organization
Center of Advanced Medicine for Dental and Oral Diseases, National Center for Geriatrics and Gerontology, Research Institute
Division name
Department of Dental Rgenerative Medicine
Zip code
474-8511
Address
35 Gengo, Morioka, Obu, Aichi, 474-8522, Japan
TEL
0562468684
misako@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Iohara |
Organization
National Center for Geriatrics and Gerontoogy
Division name
Department of Dental Rgenerative Medicine
Zip code
474-8511
Address
35 Gengo, Morioka, Obu, Aichi, 474-8522, Japan
TEL
0562468684
Homepage URL
iohara@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology, Research Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Aichi Gakuin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology, Research Institute
Address
35 Gengo, Morioka, Obu, Aichi, 474-8522, Japan
Tel
0562-46-2311
misako@ncgg.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008691
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
