UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025819 |
|---|---|
| Receipt number | R000029403 |
| Scientific Title | Multicenter study to evaluate efficacy and safety of FINESIA system in dental implant treatment. |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2023/02/24 15:59:03 |
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Basic information
Public title
Multicenter study to evaluate efficacy and safety of FINESIA system in dental implant treatment.
Acronym
FINESIA Study
Scientific Title
Multicenter study to evaluate efficacy and safety of FINESIA system in dental implant treatment.
Scientific Title:Acronym
FINESIA Study
Region
| Japan |
Condition
Condition
Single tooth gaps in premolar region, first molar and second molar.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the FINESIA bone level implant used on patients in two-stage implant placement, by assessing marginal bone loss, bone fixation, and inflammation of the gums, etc.
Furthermore, to clarify whether micromotion is reduced and the preventions of inflammation and marginal bone loss can be expected.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Marginal bone loss
Key secondary outcomes
Survival rate
Success rate
Bone fixation(Implant stability quotient)
Inflammation of the gums
Plaque
Radiographic assessment
Adverse events and device deficiencies
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects with an indication for dental implant treatment in a single tooth gaps in premolar region, first molar and second molar including last molar, who consent to the operation (both maxilla and mandible can be included).
2) Subjects with a first-person voluntary consent to participate in this clinical study, which can be obtained in writing (inpatients, outpatients, or both gender can be included).
3) Subjects aged from 20 to 70 years, at the time of a written consent.
Key exclusion criteria
1) The exclusion criteria for study device.
(1) Patients with hemorrhagic diathesis.
(2) Patients with metabolic or endocrine diseases that may significantly affect postoperative bone formation (severe osteoporosis and others).
(3) Patients taking steroids that may affect the postoperative healing of tissues.
(4) Patients with uncontrolled diabetes.
(5) Patients with strong bruxism or in overloading condition.
(6) Patients known to be allergic to the metal (titanium alloy) used in this product.
(7) Patients with a history of radiotherapy at the site of implantation.
(8) Patients for whom postoperative care cannot be controlled such as the following:
- Patients with dementia or other mental disabilities
- Patients with drug addiction
- Patients with alcoholism
(9) Patients with excessive expectation for implant functions.
(10) Patients with insufficient width and height of bone (bone mass) around the implant (patients who need combination therapy of bone prosthetic materials).
(11) Patients with a history of impaired healing.
(12) Patients with insufficient width of alveolar mucosa around the penetration site of the implant.
(13) Patients with unstable adjacent abutment teeth.
(14) Patients with serious cardiovascular disease such as myocardial infarction.
(15) Pregnant or breast-feeding patients.
(16) Other patients who are not adequate to participate this study.
*Additionally, the exclusion criteria for clinical study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Marukawa |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Regenerative and Reconstructive Dental Medicine
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, TOKYO, JAPAN
TEL
03-5803-5773
eriko.m.osur@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Marukawa |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Regenerative and Reconstructive Dental Medicine
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, TOKYO, JAPAN
TEL
03-5803-5773
Homepage URL
eriko.m.osur@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
KYOCERA Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dental Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, TOKYO, JAPAN
Tel
03-5803-5404
d-hyoka.adm@tmd.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 | 01 | Month | 24 | 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
40
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029403
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| Registered date | File name |
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