UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038590 |
|---|---|
| Receipt number | R000043978 |
| Scientific Title | The long term assessment of the augmented bone by the sinus floor augmentation. |
| Date of disclosure of the study information | 2019/11/14 |
| Last modified on | 2022/11/16 12:15:58 |
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Basic information
Public title
The long term assessment of the augmented bone by the sinus floor augmentation.
Acronym
The long term assessment of the augmented bone by the sinus floor augmentation.
Scientific Title
The long term assessment of the augmented bone by the sinus floor augmentation.
Scientific Title:Acronym
The long term assessment of the augmented bone by the sinus floor augmentation.
Region
| Japan |
Condition
Condition
tooth missing
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the decreasing rate of the augmented bone after the sinus floor augmentation with various materials.
Basic objectives2
Others
Basic objectives -Others
the change of the shape of the graft material.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the amount of the change of the augmented bone after the sinus floor augmentation.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Tapient who underwent the dental implant treatment after the sinus floor augmentation.
Key exclusion criteria
taking BP drug or anti-RANKL monoclonal drug.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
sohba@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
Homepage URL
sohba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7704
sohba@nagasaki-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
| 2019 | Year | 11 | 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
12
Results
Augmented bone volume tended to be decreased by the angle between the lateral and medial bone of the maxillary sinus floor.
Results date posted
| 2021 | Year | 11 | Month | 25 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
now writing.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
bone volume.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
now writing the article.
finalizing.
Management information
Registered date
| 2019 | Year | 11 | Month | 14 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043978
