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

Not Applicable

• Conditions: Dental Implantation
• Interventions: Device: ImplantLock device

• Registration Number: NCT00519571
• Lead Sponsor: Innovative Implant Solutions

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 Timeline

• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-22
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-08
• Last Update Posted: 2008-05-09
• Study Start: 2008-07
• Primary Completion: 2009-06
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ImplantLock device	-

Primary Outcome Measures

Name	Time	Method
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hadassah Medical center; 🇮🇱 Jerusalem, Israel