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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035318
Receipt No. 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 2018/12/19

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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
Email 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
Email nagako@dent.niigatau.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 28 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
2018 Year 12 Month 19 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040240

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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