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Research of the utility of newly developed implant system (Octafix)

Research of the utility of newly developed implant system (Octafix) - Research of dental implant system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006183
Enrollment
50
Registered
2011-08-17
Start date
2011-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

missing tooth

Interventions

We will put an Octafix implant into a place of missing tooth. We will follow for up to 5 years. Evaluation and test items &lt
Treatment evaluation&gt
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. &lt
Absorption rate of a peripheral bone&gt
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
Consideration of the period to osseointegration&gt
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.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026