UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041464 |
|---|---|
| Receipt number | 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 | 2022/02/22 11:35:26 |
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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
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
asahina@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
8
Results
The conditions of all dental implants were uneventful throughout the follow-up period. Augmented bone volume and changing rate of augmented bone volume were essentially unchanged following maturation of the OCP/Col-derived new bone. Mean marginal bone loss was 1.76 mm with the simultaneous approach, and 0.50 mm with the staged approach at five years postoperatively.
Results date posted
| 2022 | Year | 02 | Month | 22 | Day |
Results Delayed
Results Delay Reason
paper submitted
Date of the first journal publication of results
Baseline Characteristics
1. Individuals who had been included in the clinical trial
entitled "A multi-center single arm clinical trial of bone regenerative material OCP/Col", which was
registered as Trial No.UMIN000018192 and was conducted between 2015 and 2017; and who had
received maxillary sinus floor augmentation via the lateral window approach at Nagasaki University
Hospital. 2. Individuals aged between 20 and 79 years old at the time of providing consent.
Participant flow
8 out of 10 subjects were agreed to participate the study.
Adverse events
none
Outcome measures
The primary outcome was the evaluation of clinical dental implant conditions such as infection, peri-implantitis, dental implant stability, pain, and paresthesia. Secondary outcomes were the evaluation of the augmented bone volume, change rate of augmented bone volume, vertical bone height, and marginal bone loss around dental implant fixture.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
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
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047113
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| Registered date | File name |
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