UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027566 |
|---|---|
| Receipt number | R000031606 |
| Scientific Title | Clinical study of sinus floor augmentation by hydroxyapatite/collagen composite material |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2021/11/18 02:02:22 |
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Basic information
Public title
Clinical study of sinus floor augmentation by hydroxyapatite/collagen composite material
Acronym
Sinus floor augmentation by HAp/Col
Scientific Title
Clinical study of sinus floor augmentation by hydroxyapatite/collagen composite material
Scientific Title:Acronym
Sinus floor augmentation by HAp/Col
Region
| Japan |
Condition
Condition
missing tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess bone negeneration for sinus flooraugmentation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ISQ 6 months after implantation.
Key secondary outcomes
1. new bone formation.
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who needs sinus floor augmentation for dental implantation.
Key exclusion criteria
1. uncontrolled DM
2. severe renal and hepatic disorders.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Division of 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
Division of 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
| 2017 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/josnusd/63/3/63_21-0163/_article/-char/ja/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/josnusd/63/3/63_21-0163/_article/-char/ja/
Number of participants that the trial has enrolled
11
Results
This material induces the new bone formation in the maxillary sinus. On the other hand, some implants could not acquire the osseointegration when the original bone volume was insufficient.
Results date posted
| 2021 | Year | 11 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nineteen implants were placed into 14 maxillary sinuses.
Participant flow
Two implants were placed in 2 maxillary sinuses via the crestal approach, and 17 implants (OsseoSpeed; 10 implants, Finesia; 1 implant, Straumann; 6 implants) were placed in 12 maxillary sinuses via the lateral approach.
Adverse events
Three implants were lost.
Outcome measures
The alveolar bone height and cortical bone thickness of the alveo- lar bone ridge (cortical bone thickness) at the implant placement positions were measured on preoperative CBCT (3D Accuitomo F17D, Morita, Kyoto, Japan) images.　Insertion torque and ISQ were also measured.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
presentation at the annual meeting of Japanese association of oral implanvology in 23018.
Stop the exam.
Management information
Registered date
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2021 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031606
