UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006183 |
|---|---|
| Receipt number | R000007242 |
| Scientific Title | Research of the utility of newly developed implant system (Octafix) |
| Date of disclosure of the study information | 2011/08/17 |
| Last modified on | 2011/08/17 15:50:57 |
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Basic information
Public title
Research of the utility of newly developed implant system (Octafix)
Acronym
Research of dental implant system
Scientific Title
Research of the utility of newly developed implant system (Octafix)
Scientific Title:Acronym
Research of dental implant system
Region
| Japan |
Condition
Condition
missing tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this research is to consider the clinical utility of Octafix implant, which is newly put on the market.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will put an octa-fix implant into a place of missing tooth. We will follow for up to 5 years.
Evaluation and test items
<Treatment evaluation>
Success rate of implant therapy: whether or not the implant is functioning soundly.
Survival rate of implant therapy: whether or not the implant is remaining.
<Absorption rate of a peripheral bone>
We will take dental X-rays shortly after an implant is put into a bone, and the superstructure is fixed. Furthermore, we will take dental X-rays 12 months, 24 months, 36 months, (and 60 months) after the superstructure is fixed. Then, we will evaluate absorption rate of a peripheral bone with dental X-ray photos.
<Consideration of the period to osseointegration>
Only for specific patients.
We will use an implant-mobility indicator (Ostel ISQ). We will measure implant mobility shortly after an implant is put into a bone, and every 2 weeks for 16 weeks.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We will put an Octafix implant into a place of missing tooth. We will follow for up to 5 years.
Evaluation and test items
<Treatment evaluation>
Success rate of implant therapy: whether or not the implant is functioning soundly.
Survival rate of implant therapy: whether or not the implant is remaining.
<Absorption rate of a peripheral bone>
We will take dental X-rays shortly after an implant is put into a bone, and the superstructure is fixed. Furthermore, we will take dental X-rays 12 months, 24 months, 36 months, (and 60 months) after the superstructure is fixed. Then, we will evaluate absorption rate of a peripheral bone with dental X-ray photos.
<Consideration of the period to osseointegration>
Only for specific patients.
We will use an implant-mobility indicator (Ostel ISQ). We will measure implant mobility shortly after an implant is put into a bone, and every 2 weeks for 16 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient that loses more than one tooth, desires implant therapy, and that the attending dentist considers is suitable for implant therapy.
1)Patient that can receive prosthesis therapy of fixed superstructure
2)Patient that understands the aim of this research, and cooperates for long periods of time
Key exclusion criteria
1) patient with immunodeficiency (a long course of antibiotics, use of steroid, use of immunosuppressive drug)
2) patient expected to bring on incomplete cure of bone(use of bisphosphonate, after radiation to head and neck area, etc.)
3) patient with severe metabolic disease or mal-controlled metabolic disease
4) patient with kidney failure
5) patient with contraindication to surgical management
6) parturient
7) patient whose oral hygiene is poor
8) patient that needs large-sized bone augmentation (except for GBR, small-sized bone graft to socket, etc.)
9) patient with mucosal disease on the place of implant therapy
10) patient with heavy bruxism
11) patient that the attending dentist considers is unsuitable for implant therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIroshi Kurita |
Organization
Shinsyu University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
3-1-1,Asahi,Matsumoto,Nagano
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinsyu University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
TEL
0263-37-2677
Homepage URL
Sponsor or person
Institute
Department of Dentistry and Oral Surgery,Shinsyu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yoshioka, Inc.
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
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
| 2011 | Year | 08 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2011 | Year | 08 | Month | 17 | Day |
Last modified on
| 2011 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007242
