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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006183
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Dentistry and Oral Surgery,Shinsyu University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007242

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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