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

N/AUnknownNCT00519571

Innovative Implant Solutions15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Implantation

Interventions

ImplantLock deviceDEVICE

dental implant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hadassah Medical center

Jerusalem, Israel

Outcomes

Primary Outcomes

Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device

Time frame: 12 months

Secondary Outcomes

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

Central Contacts

Hanna Levy, Dr

CONTACT

972-4-638-8837 hanna@qsitemed.com

Data from ClinicalTrials.gov

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