Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
NCT ID: NCT00519571
Last Updated: 2008-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2008-07-31
2009-07-31
Brief Summary
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Detailed Description
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* Serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device will be documented in Serious Adverse Event Form.
* Adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device will be documented in Adverse Event Form.
Secondary Endpoints
* Determine 8.0 mm long endosseous implant stability while using ImplantLock Device. Stability will be routinely assessed.
* Determine the ability to immediately apply continuous functional loading on 8.0 mm long endosseous implant while using ImplantLock Device. The ability to immediately apply continuous functional loading will be routinely assessed.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
ImplantLock device
dental implant
Interventions
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ImplantLock device
dental implant
Eligibility Criteria
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Inclusion Criteria
* Subject is schedule for endosseous implantation treatment.
* Subject able to comprehend and give informed consent for participation in this study.
* Signed informed consent form.
Exclusion Criteria
* Acute infection requiring intravenous antibiotics at the time of screening.
* Bleeding disorders.
* Uncontrolled diabetes mellitus
* HIV positive or any other immunosuppressive disorder.
* Renal failure (Serum creatinine \>2.0 mg/dl).
* Subject with allergies to metal alloys.
* Coagulation disorder.
* Infection / abscess / pains in treatment target area.
* Pregnant or nursing woman.
* Resent history of alcohol or drug abuse (within the last 2 years).
* Subject is smoking.
* Subject is suffering extreme general weakness.
* Subject objects to the study protocol.
* Known cognitive or psychiatric disorder
* Concurrent participation in any other clinical study.
* Physician objection.
18 Years
80 Years
ALL
Yes
Sponsors
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Innovative Implant Solutions
INDUSTRY
Responsible Party
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IIS Ltd
Principal Investigators
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Isaac Tayeb, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Hanna Levy, Dr.
Role: primary
Other Identifiers
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IL-01
Identifier Type: -
Identifier Source: org_study_id