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

Dental Implantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00519571
• Other study ID #: IL-01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 20, 2007
• Last updated: May 8, 2008
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2008
• Source: Innovative Implant Solutions
• Contact: Hanna Levy, Dr
• Phone: 972-4-638-8837
• Email: hanna[@]qsitemed.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Dental Implantation

Intervention

Device:
• ImplantLock device
dental implant

Locations

Country	Name	City	State
Israel	Hadassah Medical center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Implant Solutions

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device		12 months	Yes
Secondary	Determine endosseous implant stability while using ImplantLock Device		12 months	No
Secondary	Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device		12 months	No