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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 because the information has not been verified recently.
Verified May 2008 by Innovative Implant Solutions.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Innovative Implant Solutions
ClinicalTrials.gov Identifier:
NCT00519571
First received: August 20, 2007
Last updated: May 8, 2008
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention
Dental Implantation
 Device: ImplantLock device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory

Further study details as provided by Innovative Implant Solutions:

Primary Outcome Measures:
  • Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine endosseous implant stability while using ImplantLock Device [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: ImplantLock device
dental implant

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519571

Contacts
Contact: Hanna Levy, Dr 972-4-638-8837 hanna@qsitemed.com

Locations
Israel
Hadassah Medical center Not yet recruiting
Jerusalem, Israel
Contact: Hanna Levy, Dr.     972-4-638-8837     hanna@qsitemed.com    
Sponsors and Collaborators
Innovative Implant Solutions
Investigators
Principal Investigator: Isaac Tayeb, Dr. Hadassah Medical Center,Israel
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, IIS Ltd
ClinicalTrials.gov Identifier: NCT00519571     History of Changes
Other Study ID Numbers: IL-01
Study First Received: August 20, 2007
Last Updated: May 8, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Innovative Implant Solutions:
Dental Implantation, Endosseous

ClinicalTrials.gov processed this record on June 17, 2013