UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027392 |
|---|---|
| Receipt number | R000031316 |
| Scientific Title | Study on the effects of hydroxyapatite (HA) and artificial bone prosthesis made of beta-TCP in implant treatment (randomized controlled trial) |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2019/11/19 19:14:48 |
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Basic information
Public title
Study on the effects of hydroxyapatite (HA) and artificial bone prosthesis made of beta-TCP in implant treatment (randomized controlled trial)
Acronym
Study on the effects of artificial bone prosthesis (HA and beta-TCP) in implant treatment
Scientific Title
Study on the effects of hydroxyapatite (HA) and artificial bone prosthesis made of beta-TCP in implant treatment (randomized controlled trial)
Scientific Title:Acronym
Study on the effects of artificial bone prosthesis (HA and beta-TCP) in implant treatment
Region
| Japan |
Condition
Condition
patients with bone defect
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effects of artificial bone prosthesis for bone augmentation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival rate after one year of the dental implant placed in the augmented bone
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Duration:1 year
Bone formation using cerasorb or Arrowbone beta dental at the same time as the dental implant placement or 2nd term is performed and bone level is confirmed by dental radiograph 1 year after implant placement.
Interventions/Control_2
Duration:1 year
Bone formation using neobone at the same time as the dental implant placement or 2nd term is performed and bone level is confirmed by dental radiograph 1 year after implant placement.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with albeolar bone defect
Key exclusion criteria
patient with poor general condition
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Suehiro |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Oral and Maxillofacial Prosthodontics
Zip code
8908544
Address
8-35-1 Sakuragaoka, Kagoshima 890-8544
TEL
099-275-6222
fsuehiro@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Suehiro |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Oral and Maxillofacial Prosthodontics
Zip code
8908544
Address
8-35-1 Sakuragaoka, Kagoshima 890-8544
TEL
099-275-6222
Homepage URL
fsuehiro@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
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
Kagoshima University hospital, Division of clinical trial
Address
8-35-1 Sakuragaoka, Kagoshima 890-8544
Tel
0992755553
crmc@m2.kufm.kagoshima-u.ac.jp
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
| 2017 | Year | 05 | Month | 31 | 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
9
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 | 02 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031316
| 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 |
