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Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Innovative Implant Solutions.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519571
First Posted: August 22, 2007
Last Update Posted: May 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Innovative Implant Solutions
August 20, 2007
August 22, 2007
May 9, 2008
July 2008
June 2009   (Final data collection date for primary outcome measure)
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device [ Time Frame: 12 months ]
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device. [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00519571 on ClinicalTrials.gov Archive Site
  • Determine endosseous implant stability while using ImplantLock Device [ Time Frame: 12 months ]
  • Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device [ Time Frame: 12 months ]
• Determine endosseous implant stability while using ImplantLock Device. • Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device. [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Dental Implantation
Device: ImplantLock device
dental implant
Experimental: 1
Intervention: Device: ImplantLock device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
July 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00519571
IL-01
No
Not Provided
Not Provided
Dr. Hanna Levy, Clinical Study Consultant, IIS Ltd
Innovative Implant Solutions
Not Provided
Principal Investigator: Isaac Tayeb, Dr. Hadassah Medical Center,Israel
Innovative Implant Solutions
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP