UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024036 |
|---|---|
| Receipt number | R000027190 |
| Scientific Title | Study of the effectiveness of the hydroxyapatite (HA) and b-TCP artificial bone graft material in implant treatment(Randomized controlled trials) |
| Date of disclosure of the study information | 2016/09/14 |
| Last modified on | 2016/09/13 20:08:26 |
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Basic information
Public title
Study of the effectiveness of the hydroxyapatite (HA) and b-TCP artificial bone graft material in implant treatment(Randomized controlled trials)
Acronym
Study of the effectiveness of the artificial bone graft material
Scientific Title
Study of the effectiveness of the hydroxyapatite (HA) and b-TCP artificial bone graft material in implant treatment(Randomized controlled trials)
Scientific Title:Acronym
Study of the effectiveness of the artificial bone graft material
Region
| Japan |
Condition
Condition
missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to use the HA-made artificial bone substitute material and b-TCP artificial bone filling material to bone augmentation at the time of implant treatment to examine its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of bone augmentation site by CT imaging
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
Hydroxyapatite group
Interventions/Control_2
b-TCP group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects that there is a defect site of the tooth that requires the implant treatment with a bone augmentation.
Key exclusion criteria
Patients with underlying disease can not be performed the implant treatment and excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shimotahira naohiro |
Organization
Kagoshima university
Division name
Department of oral and maxillofacial prosthodontics
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-6222
n-shimo@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shimotahira naohiro |
Organization
Kagoshima university
Division name
Department of oral and maxillofacial prosthodontics
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-6222
Homepage URL
n-shimo@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima university
Institute
Department
Personal name
Funding Source
Organization
Kagoshima 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
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
| 2016 | Year | 09 | Month | 14 | 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
Date of protocol fixation
| 2016 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 02 | 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
| 2016 | Year | 09 | Month | 13 | Day |
Last modified on
| 2016 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027190
