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

Innovative Implant Solutions

Status

Unknown

Conditions

Dental Implantation

Treatments

Device: ImplantLock device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00519571

IL-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.