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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041464
Receipt No. R000047113
Scientific Title Long-term observation study for maxillary sinus floor augmentation using octa-calcium phosphate/collagen composite
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/19

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Basic information
Public title Long-term observation study for maxillary sinus floor augmentation using octa-calcium phosphate/collagen composite
Acronym Long-term observation for maxillary sinus floor augmentation using OCP/collagen
Scientific Title Long-term observation study for maxillary sinus floor augmentation using octa-calcium phosphate/collagen composite
Scientific Title:Acronym Long-term observation for maxillary sinus floor augmentation using OCP/collagen
Region
Japan

Condition
Condition alveolar bone atrophy
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of dental implants newly formed bone 5 years after maxillary sinus floor augmentation using OCP/Col composite
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dental implant status (infection, peri-implantitis, dental implant stability, pain, paresthesia) 5 years after maxillary sinus floor augmentation using OCP/Col composite
Key secondary outcomes CT value (HU unit), vertical bone hight, new bone volume 5 years after maxillary sinus floor augmentation using OCP/Col composite

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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who were included in the clinical trial "a multi-center single arm clinical trial of bone regenerative material; OCP/Col"
Key exclusion criteria Patients who are treated for bone metabolic diseases such as osteoporosis and who are taking bisphosphonate drugs
Target sample size 11

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Asahina
Organization Nagasaki University Hospital
Division name Oral Surgery
Zip code 852-8588
Address 1-7-1 Sakamoto , Nagasaki
TEL 095-819-7701
Email asahina@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Izumi
Middle name
Last name Asahina
Organization Nagasaki University Hospital
Division name Oral Surgery
Zip code 852-8588
Address 1-7-1 Sakamoto , Nagasaki
TEL 095-819-7701
Homepage URL
Email asahina@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Nagasaki 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 Nagasaki University Hospital
Address 1-7-1 Sakamoto , Nagasaki
Tel 095-819-7701
Email asahina@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
2020 Year 09 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
2020 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation study of the clinical trial performed 5 years ago

Management information
Registered date
2020 Year 08 Month 19 Day
Last modified on
2020 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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