UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034729 |
|---|---|
| Receipt number | R000039597 |
| Scientific Title | Study on the time-dependent bone remodeling after dental implant treatment |
| Date of disclosure of the study information | 2018/11/05 |
| Last modified on | 2022/11/03 09:58:46 |
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Basic information
Public title
Study on the time-dependent bone remodeling after dental implant treatment
Acronym
Study on the time-dependent bone remodeling after dental implant treatment
Scientific Title
Study on the time-dependent bone remodeling after dental implant treatment
Scientific Title:Acronym
Study on the time-dependent bone remodeling after dental implant treatment
Region
| Japan |
Condition
Condition
Dental Implant Treatment
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factors affecting the bone changes around the dental implants after the implant prosthetic treatment
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between the time-dependent bone change around the implant and the mechanical stress distribution in bone around the implant.
To investigate the factors, which can control bone change, related to the biomechanical background of the patient by cohort study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time-dependent bone change around the implant
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Dental cone-beam CT photography
CTs are taken 3 times: Immediately after the treatment, 1 year after the treatment, 2 years after the treatment
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
(1) Patients whose implant prosthetic treatment at the tooth defective area is expected to be completed within 3 months
(2) Men and women aged 20 years or older
(3) Patients who understand the purpose and content of the research and obtained written consent for research participation from themselves
Key exclusion criteria
(1) Patients who have complications such as postoperative infection during the implant treatment
(2) Adult patients without sufficient judgment ability
(3) Patients who may be pregnant or during pregnancy
(4) Others who are judged unsuitable for this study by the dentists
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | SASAKI |
Organization
Tohoku University Graduate School of Dentistry
Division name
Advanced Prosthetic Dentistry
Zip code
9808575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8369
keiichi.sasaki.e6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | YODA |
Organization
Tohoku Unievrsity Hospital
Division name
Advanced Prosthetic Dentistry
Zip code
9808575
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8369
Homepage URL
nobuhiro.yoda.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
MHLW Certified Clinical Research Review Board, Tohoku University
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2018 | Year | 11 | Month | 05 | 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
28
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2022 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039597
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
