We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00519571
Recruitment Status : Unknown
Verified May 2008 by Innovative Implant Solutions.
Recruitment status was:  Not yet recruiting
First Posted : August 22, 2007
Last Update Posted : May 9, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Dental Implantation Device: ImplantLock device

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
Study Start Date : July 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : July 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Device: ImplantLock device
dental implant


Outcome Measures

Primary Outcome Measures :
  1. Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Determine endosseous implant stability while using ImplantLock Device [ Time Frame: 12 months ]
  2. Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, IIS Ltd
ClinicalTrials.gov Identifier: NCT00519571     History of Changes
Other Study ID Numbers: IL-01
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Innovative Implant Solutions:
Dental Implantation, Endosseous