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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035879
Receipt No. R000040510
Scientific Title A clinical study on the safety of intentional tooth re-plantation for root fracture tooth.
Date of disclosure of the study information 2019/02/22
Last modified on 2019/02/22

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Basic information
Public title A clinical study on the safety of intentional tooth re-plantation for root fracture tooth.
Acronym The intentional tooth re-plantation for root fracture tooth.
Scientific Title A clinical study on the safety of intentional tooth re-plantation for root fracture tooth.
Scientific Title:Acronym The intentional tooth re-plantation for root fracture tooth.
Region
Japan

Condition
Condition dental root fracture
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety of tooth re-plantation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety (Adverse events and safe adverse events)
Key secondary outcomes Periodontal examination

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Tooth re-plantation
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

Not applicable
Gender Male and Female
Key inclusion criteria A patient MUST:
1) Have a tooth root fracture or caries.
2) Have teeth on both sides of tooth extraction site.
3) Overall good systemic health
4) 20 years and older
5) Signed informed consent

Key exclusion criteria Patient MUST NOT:
1)Have a severe chronic periodontitis
2)Intercuspal position is not stable
3)Have bruxism
4)No history of invasive cancer
5)Taking anticoagulants or antiplatelet drugs
6)No history of oral cancer or precancerous lesion
7) Pregnancy, breastfeeding, or positive pregnancy test

Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morikuni Tobita
Organization Juntendo Hospital, Juntendo university school of medicine
Division name Dental and Oral surgery
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL 03-3813-3111
Email mtobita@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Morikuni Tobita
Organization Juntendo Hospital, Juntendo university school of medicine
Division name Dental and Oral surgery
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL 03-3813-3111
Homepage URL
Email mtobita@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Juntendo Tokyo Koto Geriatric Medical Center, Juntendo university school of medicine
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
2019 Year 02 Month 22 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 22 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 15 Day
Last modified on
2019 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040510

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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