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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019783
Receipt No. R000022840
Scientific Title Dental Implant and Oral and Maxillofacial reconstructive therapy using bioactivated titanium.
Date of disclosure of the study information 2015/11/13
Last modified on 2016/11/18

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Basic information
Public title Dental Implant and Oral and Maxillofacial reconstructive therapy using bioactivated titanium.
Acronym Oral and Maxillofacial reconstruction with bioactivated titanium.
Scientific Title Dental Implant and Oral and Maxillofacial reconstructive therapy using bioactivated titanium.
Scientific Title:Acronym Oral and Maxillofacial reconstruction with bioactivated titanium.
Region
Japan

Condition
Condition Missing teeth and bone defect
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Effect of UV-irradiated titanium materials for dental implant and bone reconstructive therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone regeneration and osseointegration at 6-month, 1-year and 2-year.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 UV-irradiation to titanium materials
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 Jaw bone defect
Missing teeth
Osteonecrosis of Jaw
Osteomyelitis
Facial trauma
Key exclusion criteria Not specified
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Hirota
Organization Yokohama City University
Division name Oral and Maxillofacial Surgery
Zip code
Address 3-9 Fukuura, Kanazawaku, Yokohama City
TEL 045-787-2800
Email mhirota@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Hirota
Organization Yokohama City University
Division name Oral and Maxillofacial Surgery
Zip code
Address 3-9 Fukuura, Kanazawaku, Yokohama City
TEL 045-787-2800
Homepage URL
Email mhirota@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 11 Month 13 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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 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
2015 Year 11 Month 13 Day
Last modified on
2016 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022840

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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