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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Implantation

Intervention / Treatment
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* Device: ImplantLock device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: ImplantLock device<br>* dental implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine endosseous implant stability while using ImplantLock Device |  | 12 months | 
| Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implantation, Endosseous