UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035318 |
|---|---|
| Receipt number | R000040240 |
| Scientific Title | Dental pulp wound healing and repair mechanism in vital pulp therapy - Investigation by immunohistochemistry and gene expression analysis - |
| Date of disclosure of the study information | 2018/12/20 |
| Last modified on | 2022/12/26 18:56:56 |
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Basic information
Public title
Dental pulp wound healing and repair mechanism in vital pulp therapy - Investigation by immunohistochemistry and gene expression analysis -
Acronym
Dental pulp wound healing and repair mechanism in vital pulp therapy
Scientific Title
Dental pulp wound healing and repair mechanism in vital pulp therapy - Investigation by immunohistochemistry and gene expression analysis -
Scientific Title:Acronym
Dental pulp wound healing and repair mechanism in vital pulp therapy
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of triple antibiotic mixture (3Mix) and Mineral Trioxide Aggregate (MTA) on wound healing and tissue repair in vital pulp therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inflammatory cell infiltration and reparative dentin formation up to 3 months after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Application of 3Mix to indirect pulp capping of deep caries
Interventions/Control_2
Application of Mineral Trioxide Aggregate (MTA) to indirect pulp capping of deep caries
Interventions/Control_3
Untreated carious teeth
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Dental caries diagnosed as extraction for orthodontic treatment.
Key exclusion criteria
Patients who have severe systemic diseases.
Tooth with severe periodontitis.
Non-vital tooth.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiko Yoshiba |
Organization
Niigata University
Division name
Graduate School of Medical and Dental Sciences
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
025-227-0697
yoshiba@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagako Yoshiba |
Organization
Niigata University
Division name
Medical and Dental Hospital
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
025-227-2866
Homepage URL
nagako@dent.niigatau.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
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
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
| 2018 | Year | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040240
