UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059751 |
|---|---|
| Receipt number | R000068329 |
| Scientific Title | Time course changes of implant stability with FINESIA Relios system |
| Date of disclosure of the study information | 2025/11/12 |
| Last modified on | 2025/11/12 19:52:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Time course changes of implant stability with FINESIA Relios system
Acronym
Time course changes of implant stability with FINESIA Relios system
Scientific Title
Time course changes of implant stability with FINESIA Relios system
Scientific Title:Acronym
Time course changes of implant stability with FINESIA Relios system
Region
| Japan |
Condition
Condition
molar tooth loss
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the temporal changes of ISQ (Implant Stability Quotient) value of FINESIA Relios system implanted in molar region
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ISQ value
Key secondary outcomes
Factors affecting ISQ value
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who want to receive an implant treatment in molar region
Key exclusion criteria
Patients with hemorrhagic diathesis
Patients with metabolic or endocrine disease that may significantly affect postoperative bone formation
Patients taking steroids that may affect postoperative healing of tissues
Patients with uncontrolled diabetes
Patients with strong bruxism or in overloading condition
Other patients who are not adequate to participate this study
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sawase |
Organization
Nagasaki University
Division name
Department of Applied Prosthodontics
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7688
sawase@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sawase |
Organization
Nagasaki University
Division name
Department of Applied Prosthodontics
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7688
Homepage URL
sawase@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Takashi Sawase
Funding Source
Organization
none
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
Ethic committee of the Graduate School of Biomedical Sciences, Nagasaki University
Address
1-12-4, Sakamoto, Nagasaki
Tel
095-819-7198
gakujutu_gakuji@ml.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
| 2025 | Year | 11 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient information, implant insertion torque, and ISQ value measurements are taken at the time of implant placement. ISQ value measurements are then taken at the following intervals: 4~8 weeks after placement during the impression for provisional restoration, 1~3 weeks after impression taking during provisional placement, and 2~6 weeks after provisional placement
Management information
Registered date
| 2025 | Year | 11 | Month | 12 | Day |
Last modified on
| 2025 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068329
