- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00519571
Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
May 8, 2008 updated by: Innovative Implant Solutions
To investigate the safety and effectiveness of the ImplantLock device and its contribution to 8.0 mm long root-form endosseous implants stability under immediately applied continuous functional loading.
Study Overview
Detailed Description
Primary Endpoints
- 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.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hanna Levy, Dr
- Phone Number: 972-4-638-8837
- Email: hanna@qsitemed.com
Study Locations
-
-
-
Jerusalem, Israel
- Hadassah Medical Center
-
Contact:
- Hanna Levy, Dr.
- Phone Number: 972-4-638-8837
- Email: hanna@qsitemed.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male/Female age 18 and up.
- 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:
- Subjects suffering from a disease that might disturb bone regeneration healing process e.g. osteoporosis, anemia, etc.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
dental implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine endosseous implant stability while using ImplantLock Device
Time Frame: 12 months
|
12 months
|
Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Isaac Tayeb, Dr., Hadassah Medical Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Anticipated)
June 1, 2009
Study Completion (Anticipated)
July 1, 2009
Study Registration Dates
First Submitted
August 20, 2007
First Submitted That Met QC Criteria
August 20, 2007
First Posted (Estimate)
August 22, 2007
Study Record Updates
Last Update Posted (Estimate)
May 9, 2008
Last Update Submitted That Met QC Criteria
May 8, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IL-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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