UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016537 |
|---|---|
| Receipt number | R000019198 |
| Scientific Title | Clinical research on bone augmentation around dental implant with Bio-Oss and B-TCP; Prospective research |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2015/02/14 12:31:54 |
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Basic information
Public title
Clinical research on bone augmentation around dental implant with Bio-Oss and B-TCP; Prospective research
Acronym
Clinical research on bone augmentation with Bio-Oss and B-TCP
Scientific Title
Clinical research on bone augmentation around dental implant with Bio-Oss and B-TCP; Prospective research
Scientific Title:Acronym
Clinical research on bone augmentation with Bio-Oss and B-TCP
Region
| Japan |
Condition
Condition
patient planning dental implant surgery with loss of teeth and alveolar bone
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
clinical evaluation of unresolvable bone substitute (Bio-Oss)and resolvable substitute(B-TCP) in dental implant treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival of dental implant
Key secondary outcomes
Base
Study type
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
| Device,equipment |
Interventions/Control_1
usage of unresorbable bone substitute (Bio-Oss) and resorbable bone substitute (B-TCP) in bone augmentation of dental implant treatment
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
There are taken informed concent among dental implant patients at Tohoku University hospital
Key exclusion criteria
(1) the patients who refsed the consent for this study
(2) the patient judged to be unsuitable for study participation by doctor in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenko Tanaka |
Organization
Tohoku University Hospital
Division name
Dental Implant Center
Zip code
Address
1-1 Seiryocho, Aobaku, Sendai
TEL
022-717-7000
kenkou-tanaka@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Koyama |
Organization
Tohoku University Hospital
Division name
Dental Implant Center
Zip code
Address
1-1 Seiryocho, Aobaku, Sendai
TEL
022-717-7000
Homepage URL
koyama@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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 | 02 | Month | 14 | Day |
Last modified on
| 2015 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019198
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
