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

Tracking Information

First Received Date ^ICMJE

August 20, 2007

Last Updated Date

May 8, 2008

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00519571 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

• 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Dental Implantation

Intervention ^ICMJE

Device: ImplantLock device

dental implant

Study Arm (s)

Experimental: 1

Intervention: Device: ImplantLock device

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Hanna Levy, Dr

972-4-638-8837

hanna@qsitemed.com

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00519571

Other Study ID Numbers ^ICMJE

IL-01

Has Data Monitoring Committee

Responsible Party

Dr. Hanna Levy, Clinical Study Consultant, IIS Ltd

Study Sponsor ^ICMJE

Innovative Implant Solutions

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Isaac Tayeb, Dr.

Hadassah Medical Center,Israel

Information Provided By

Innovative Implant Solutions

Verification Date

May 2008

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

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