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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025819
Receipt No. 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 2018/08/24

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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
Middle name
Last name Shohei Kasugai
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Oral Implantology and Regenerative Dental Medicine
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, TOKYO , 113-8549, JAPAN
TEL 03-5803-5934
Email kas.mfc@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shohei Kasugai
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Oral Implantology and Regenerative Dental Medicine
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, TOKYO , 113-8549, JAPAN
TEL 03-5803-5934
Homepage URL
Email kas.mfc@tmd.ac.jp

Sponsor
Institute Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
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
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029403

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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